Method of injecting fluids into multiple patients

ABSTRACT

Systems for injecting fluids and/or other materials into a targeted anatomical location, in particular, an intra-articular space, include a handpiece assembly having a proximal end and a distal end, a needle extending from the distal end of the handpiece assembly, a fluid delivery module comprising a cassette and a fluid transfer device. A conduit is generally configured to place the fluid delivery module in fluid communication with the handpiece assembly. Medications, formulations and/or other fluids or materials contained within vials that are secured to the fluid delivery module can be selectively delivered into an anatomy through a needle located at the distal end of the handpiece assembly. In some embodiments, ultrasound or other imaging technologies can be used to locate a joint or other targeted anatomical location.

CROSS REFERENCE TO RELATED APPLICATIONS

This is a continuation of U.S. patent application Ser. No. 12/340,595,filed Dec. 19, 2008, which claims the benefit under 35 U.S.C. § 119(e)of U.S. Provisional Application No. 61/016,395, filed Dec. 21, 2007, theentireties of which are hereby incorporated by reference herein.

BACKGROUND

1. Field of the Inventions

This application relates generally to injection and/or aspirationdevices, systems and methods, and more specifically, to devices, systemsand methods of delivering pharmaceuticals or other substances and/orother fluids into and/or out of an intra-articular space.

2. Description of the Related Art

Physicians, clinicians and/or other medical personnel often need todeliver a volume of medication, other fluid and/or other material to (oraspirate fluid from) an anatomical location, such as, for example ajoint (e.g., toe, knee, wrist, shoulder, ankle, finger, spine, etc.).Accordingly, a needle can be inserted through a patient's skin and intothe targeted location. A syringe or other fluid source that is in fluidcommunication with the needle can then be used to deliver the desiredvolume or other dosage of fluid and/or other material to the targetedjoint or other anatomical location.

Current injection practice generally involves palpation by the physicianof a bony prominence on the patient's anatomy to serve as a “landmark”to guide the injection into the targeted location. The injection iscompleted by advancing the needle, which is typically connected to adisposable glass or plastic syringe, into the target area. The syringeplunger is then advanced to deliver the fluid. In many cases, currenttreatment methods do not offer precise or accurate delivery.

SUMMARY

Embodiments of the present invention are particularly advantageousbecause they offer precise and accurate delivery of medications. Forexample, studies have shown that conventional needles miss the targetlocation quite frequently. Many medications utilized for the treatmentof arthritis, such as steroids and other medicaments can provide benefitto the patient only if they are injected directly into the patient'ssynovial fluid. Further, certain medications, such as steroids, breakdown connective tissue and cause other tissue damage. Therefore, whensuch medications or other formulations are not precisely delivered tothe target intra-articular location, adverse tissue damage can occur toone or more anatomical locations of patients.

Moreover, in order to deliver a second medication, other fluid and/orother material to the same anatomical location, physicians or othermedical personnel require multiple needle penetrations or leave theneedle within the targeted intra-articular space, while unhooking thetubing or other conduit which is in fluid communication with the needle.Forceps or other tools are often used to disconnect and/or connect thetubing or other conduits to the needle in order to deliver a differentmedication or fluid to the patient. This can complicate the process forthe physician or other person performing the procedure and breaks thesterile fluid path, thereby increasing the chance for infection. Inaddition, the process can prove to be uncomfortable and painful to thepatient. Thus, several embodiments of the present inventions aredirected to the delivery of two or more fluids or other medications to apatient with single needle penetration and/or without the use of toolsto disconnect and/or connect the tubing or other conduits to the needle.

According to certain embodiments, a handpiece assembly for simultaneousor sequential delivery of multiple fluids into a joint comprises a core,a clip, a disposable tip, a needle, a first lumen and a second lumen. Inany of the arrangements disclosed herein, a handpiece assembly can beconfigured to deliver medications, pharmaceutical compositions, drugs,cells, liquid and non-liquid fluids and flowable materials,nanoparticles, cement, microbeads and/or the like. In one embodiment,the handpiece assembly is configured to simultaneously or sequentiallydeliver an anesthetic and a steroid for treating a joint. In oneembodiment, the core comprises at least one button, dial, knob, switch,rollerball, rollerwheel and/or other controller configured to control arate of flow of at least one of a first fluid and a second fluid. Insome configurations, the first fluid is adapted to flow through thefirst lumen and the second fluid is configured to flow through thesecond lumen. In other arrangements, the handpiece assembly can includethree or more lumens for delivering three or more different fluidsand/or other materials to a joint or other anatomical location. Thecontroller can be configured to control whether the first and secondfluids are delivered simultaneously or sequentially through thehandpiece assembly and/or other components or portions (e.g., a tip,needle, etc.). In any of the embodiments described herein, two, three,four or more controllers are used.

In some arrangements, simultaneous delivery of said fluids is performedby combining the first and second fluids in the handpiece assembly. Inone embodiment, the core of the handpiece assembly is in datacommunication with a fluid delivery module. In other configurations, thefirst and second lumens are adapted to direct said fluids from a fluiddelivery module, through the clip, through the disposable tip and to theneedle. In another embodiment, each of the lumens comprises a valve toprevent backflow of said fluids toward the fluid delivery module. Theneedle can be configured to be removably attached to the disposable tipand the disposable tip can be configured to be removably attached to theclip. In some embodiments, the needle is configured to be positionedwithin a joint to selectively deliver at least one said first fluid orsaid second fluid to said joint.

According to other arrangements, the first and second fluids areconfigured to be combined within the clip under a simultaneous deliveryscheme. In one embodiment, the first and second fluids are configured tobe combined at or near an interface between the clip and the disposabletip under a simultaneous delivery scheme. In another embodiment, thefirst and second fluids are configured to be combined at a distal end ofthe clip, near an interface between the clip and the disposable tipunder a simultaneous delivery scheme. According to other arrangements,the first and second fluids are maintained separate until immediatelyupstream of the disposable tip. In some configurations, the handpieceassembly comprises one or more buttons and/or other controllers. In anyof the embodiments disclosed herein, a handpiece assembly can includeany type of controller, such as, multi-mode buttons, multi-depthbuttons, rheostats, dials, knobs, switches, rollerballs, rollerwheelsand/or combinations thereof.

According to certain arrangements, the one or more buttons and/or othercontrollers of the handpiece assembly are configured to control the rateof flow of at least one of the first fluid and the second fluid betweena no flow condition, a first flowrate condition and at least a secondflowrate condition. In any of the embodiments disclosed herein, thebuttons and/or other controllers are configured to have additional modesand or functions. In addition, in some arrangements, the buttons and/orother controllers are configured to control or otherwise regulate theflow of one, two, three or more different fluid and/or other materialstreams through a handpiece assembly.

In certain embodiments, the handpiece assembly further comprises a thirdlumen, such that a third fluid is configured to be selectively conveyedtherethrough. In one arrangement, the one or more buttons and/or othercontrollers are configured to control a rate of flow of the first fluid,the second fluid and/or the third fluid. The fluids being conveyedthrough the handpiece assembly can be configured to flow from the fluiddelivery module to the needle either sequentially or simultaneously. Forexample, in one embodiment, two or more of the various fluid and/orother material streams can be delivered simultaneously through thehandpiece assembly and the downstream needle.

According to certain arrangements, the core of the handpiece assemblyincludes a first controller configured to control the rate of flow ofthe first fluid, a second controller configured to control the rate offlow of the second fluid and a third controller configured to controlthe rate of flow of the third fluid. In any of the embodiments describedherein, the buttons or other controllers on the core or other portionsof the handpiece assembly can be used to control one or more otherproperties or aspects of the injection procedure. For example, in oneembodiment, the buttons and/or other controllers control an ultrasoundor other imaging device, regulate the sequence of delivery and/or thelike. In another embodiment, at least one function of the imaging deviceor system is configured to be selectively controlled by an imagingcontroller and/or another portion or component of the handpiece. In somearrangements, the imaging controller of the handpiece comprises abutton, dial, switch, knob, rollerball, rollerwheel and/or the like.

In some embodiments, a handpiece device for use in an anatomicalinjection system comprises an outer housing enclosing a handpieceinterior. The outer housing of the handpiece device or assembly can beconfigured to be grasped and manipulated by a user. In somearrangements, the handpiece device additionally includes a first andsecond conduit routed through the handpiece interior. In otherarrangements, more or fewer conduits may be routed through thehandpiece. According to one embodiment, the handpiece device furthercomprises a disposable tip having a first end and a second end, with thefirst end being adapted to removably receive a needle and the second endconfigured to secure to the outer housing.

In one embodiment, the first conduit is configured to place the needlein fluid communication with a first reservoir of a fluid delivery moduleand the second conduit is configured to place the needle in fluidcommunication with a second reservoir of the fluid delivery module. Inalternative embodiments, additional conduits can place the needle influid communication with additional reservoirs of the fluid deliverymodule. In certain embodiments, the handpiece device includes at leastone button or other controller positioned along the outer housing. Sucha button or other controller can be adapted to selectively regulate aflow of fluids through at least one of the first conduit, the secondconduit and/or any additional conduits that may be present. In someconfigurations, the handpiece device is adapted to deliver fluids and/orother materials through the first and second conduits to the needlesimultaneously or sequentially. In one embodiment, each of the conduitscomprises a check valve, a duckbill valve and/or any other type of valveto prevent fluid backflow toward the fluid delivery module. The needlepositioned at the distal end of the handpiece device can be positionedwithin a joint to selectively deliver fluids thereto.

According to other arrangements, the one or more buttons and/or othercontrollers are in data communication with a fluid delivery moduleand/or any other portion of the injection system. The handpiece canadditionally include a common chamber located upstream of the needle,wherein such a common chamber is configured to receive fluids and/orother materials from the first and second conduits. In any of theembodiments disclosed herein, the handpiece can include additionalconduits configured to deliver fluids and/or other materials to a commonchamber or other portion or area of the handpiece. In someconfigurations, the common chamber is located at or near a distal end ofthe outer housing of the handpiece device. However, in otherembodiments, the common chamber is located at or near an interfacebetween the outer housing and the disposable tip. In certainarrangements, the controller includes one or more buttons, dials, knobs,switches, rollerballs, rollerwheels, other controller and/or any otherdevice configured to allow a user to regulate one or more aspects of aninjection procedure.

According to some embodiments, an injection system configured forsimultaneous or sequential delivery of different fluids into a patientincludes a fluid delivery module adapted to receive a first containerand at least a second container. In some arrangements, the fluiddelivery module is configured to receive three or more vials or othercontainers. In one embodiment, the fluid delivery module comprises afirst reservoir, a second reservoir and/or additional reservoirs thatare configured to be placed in fluid communication with fluids and/orother materials contained within the containers secured to the fluiddelivery module. In certain embodiments, the injection additionallyincludes a handpiece comprising a core, a clip, a disposable tip, aneedle positioned at a distal end of said disposable tip, a firstconduit and at least a second conduit. In some arrangements, the corecomprises one or more buttons and/or other controllers configured tocontrol a rate of flow of fluids through the first conduit and/or thesecond conduit. Such buttons and/or other controllers can be configuredto control the flow of fluids through additional conduits that may beincluded in a handpiece assembly. In other embodiments, the buttonsand/or other controllers can regulate one or more other aspects of theinjection system and/or devices or systems operatively connected to theinjection system, such as, an ultrasound or other imaging device. Incertain arrangements, at least one function of the imaging device orsystem is configured to be selectively controlled by an imagingcontroller and/or another portion or component of the handpiece. In somearrangements, the imaging controller of the handpiece comprises abutton, dial, switch, knob, rollerball, rollerwheel and/or the like.

In some arrangements, the first fluid is configured to flow through thefirst conduit and the second fluid is configured to flow through thesecond conduit. In embodiments that include more than two conduits,additional fluids and/or other materials can be configured to beconveyed through such conduits. According to some arrangements, thefirst and second conduits are configured to direct fluids and/or othermaterials from the fluid delivery module, through the clip and thedisposable tip and to the needle. The one or more buttons and/or othercontrollers of the handpiece assembly can be configured to controlwhether the first, second and/or additional fluids are delivered fromthe fluid delivery module to the needle simultaneously or sequentially.In one embodiment, the simultaneous delivery of fluids and/or othermaterials is performed by combining the fluids in the handpiece.According to certain arrangements, the core is in data communicationwith the fluid delivery module. Further, each of the conduits caninclude a valve or other feature or device to help prevent backflow ofthe fluids from the handpiece toward the fluid delivery module. In someembodiments, the disposable tip is configured to be removably attachedto the clip. In any of the embodiments described herein, the needle isconfigured to be positioned within a target anatomical location toselectively deliver one or more medicants, other fluids and/or othermaterials to a joint or other anatomical location of a patient.

In some embodiments, the controller comprises at least one button, dial,knob, switch, lever, rollerball, rollerwheel, other modulating deviceand/or the like. According to other arrangements, the handpiece assemblycomprises a multi-function button configured to permit a user to selectbetween a no flow condition and at least two flow conditions of varyingspeed. In one embodiment, such a button permits a user to selectivelyadjust the flowrate or any other flow property of one or more fluidsand/or other materials being conveyed through the handpiece assembly.For example, the button and/or other controller can permit a user tochoose between two, three or more distinct flowrates. Alternatively, therheostat, button and/or other controller can permit a user to selectbetween various non-distinct flowrates or other settings. In certainarrangements, the handpiece assembly includes one or more multi-depthbuttons that are configured to be moved to one of two, three or moredifferent depths. In one embodiment, each distinct or non-distinct depthcorresponds to a different rate of flow for the first fluid, the secondfluid and/or additional fluids and/or other materials being conveyedfrom the fluid delivery module to the needle. According to otherembodiments, the core comprises a battery that is configured to berecharged using induction, simple charging (e.g., using a DC or ACconnection), pulse charging and/or other charging methods or devices. Insome arrangements, the battery of the core is configured to beinductively or otherwise recharged when the handpiece is positionedwithin a docking station of the fluid delivery module.

According to certain embodiments disclosed in the present application, amethod of injecting two, three or more fluids into a joint or otheranatomical location (e.g., organ, bone, etc.) of a patient using ahandpiece assembly includes providing a handpiece assembly. In somearrangements, the handpiece assembly includes a core, a clip, adisposable tip, a needle, a first conduit and a second conduit. In otherconfigurations, the handpiece assembly comprises three or more conduits.A first fluid or other material is configured to flow through the firstconduit and a second fluid or other material is configured to flowthrough the second conduit. Other fluids or materials can be configuredto flow through additional conduits of the handpiece assembly. In oneembodiment, the core comprises at least one button or other controlleradapted to control a rate of flow and/or other flow characteristics ofthe first fluid, second fluid and/or other fluids or materials beingconveyed through the conduits of the handpiece assembly.

In certain embodiments, the core is configured to be in data and fluidcommunication with a fluid delivery module. The first, second and/oradditional conduits are configured to convey fluids and/or othermaterials through the clip and the disposable tip, and to the needle.The conduits are routed through an interior of the handpiece assembly.In addition, the each conduit comprises a valve or other device toprevent backflow of fluids and/or materials flowing therethrough. Insome embodiments, the needle is configured to be removably attached tothe disposable tip, and the disposable tip is configured to be removablyattached to the clip of the handpiece assembly. The needle is configuredto be positioned within a joint or other anatomical location toselectively deliver a first fluid, a second fluid and/or additionalfluids or materials to a target joint or other anatomical location.

The method additionally comprises positioning the needle into a joint orother target anatomical location of a patient, and delivering a volumeof the first fluid, the second fluid and/or additional fluids ormaterials to the needle. In some arrangements, the one or more buttonsand/or other controllers of the handpiece assembly are configured tocontrol a rate of flow of the first fluid, second fluid and/oradditional fluids or materials through the conduits. In one embodiment,the one or more controllers control whether the first and second fluidsare delivered simultaneously or sequentially. In other arrangements,simultaneous delivery of fluids and/or other materials is performed bycombining the first, second and/or additional fluids and/or othermaterials in the handpiece assembly. In some embodiments, the fluids areconfigured to be combined within the clip, at or near an interfacebetween the clip and the disposable tip at a distal end of the clip,near an interface between the clip and the disposable tip and/or at anyother location of the handpiece assembly. In one embodiment, the variousfluids and/or other materials conveyed through the handpiece assemblyare maintained separate until immediately upstream of the disposabletip.

According to certain arrangements, the controller comprises one or morebuttons, dials, knobs, switches, rollerballs, rollerwheels and/or anyother devices adapted to be modulated or adjusted. The buttons or othercontrollers are configured to regulate the rate of flow of the firstfluid, the second fluid and/or any other fluids adapted to pass throughthe handpiece assembly. In some embodiments, such buttons or othercontrollers can permit a user to select between a no flow condition, afirst flowrate condition and at least a second flowrate condition. Insome arrangements, the handpiece assembly additionally includes a thirdconduit configured to convey a third fluid and/or other materialtherethrough. The buttons and/or other controllers can be configured tocontrol a rate of flow of the first fluid, second fluid, third fluidand/or additional fluids or other materials. In one embodiment, thefluids are configured to sequentially or simultaneously flow through theclip and the disposable tip of the handpiece assembly to the needle. Inother embodiments, the core comprises a first button or controllerconfigured to control a rate of flow of the first fluid, a second buttonor controller configured to control a rate of flow of the second fluidand a third button or controller configured to control a rate of flow ofthe third fluid. Additional buttons or other controllers can be providedto regulate the flow of additional fluid or other material streamsthrough the handpiece assembly. According to some configurations, themethod additionally comprises monitoring a position of a distal end ofthe needle using an ultrasound, radio frequency, spectroscopy and/orother imaging device or system to accurately locate a target joint orother anatomical location of the patient. In some arrangements, at leastone function of the imaging device or system is configured to beselectively controlled by an imaging controller and/or another portionor component of the handpiece. In some arrangements, the imagingcontroller of the handpiece comprises a button, dial, switch, knob,rollerball, rollerwheel and/or the like.

In certain embodiments, a method of injecting two, three or moremedicaments, fluids and/or other materials into an anatomy using ahandpiece assembly includes providing a handpiece assembly thatcomprises a main body and needle removably positioned at a distal end ofthe main body. The handpiece assembly includes a first conduit and atleast a second conduit that are positioned within an interior of themain body. In any of the embodiments described herein, the method caninclude the injection of three or more medicaments, fluids and/or othermaterials. A first fluid or other material is configured to flow througha first conduit, and a second fluid or other material is configured toflow through the second conduit. In one embodiment, the main bodycomprises at least one button and/or other controller configured toregulate a rate of flow of the first fluid, the second fluid and/oradditional fluids or materials through the various conduits of thehandpiece assembly. The handpiece assembly is configured to be in dataand fluid communication with a fluid delivery module. In certainarrangements, the first and second conduits are configured to conveyfluids and/or other materials to the needle. Each of the conduits caninclude a valve and/or other retrograde flow devices to prevent backflowof the fluids and/or other materials toward a proximal end of the mainbody. According to some embodiments, the needle is configured to bepositioned within a target anatomical location to selectively deliver avolume of the first fluid, the second fluid and/or additional fluids ormaterials to a target anatomical location. The method further comprisespositioning the needle into an anatomy and delivering a volume of thefirst fluid, the second fluid and/or additional fluids or materialsthrough the conduits to the needle. In some embodiments, positioning theneedle into an anatomy comprises using an ultrasound, radio frequency,spectroscopy and/or other imaging device or system to accurately locatethe target anatomical location. The one or more buttons and/or othercontrollers are configured to control a rate of flow of the first fluid,the second fluid and/or additional fluid or other material streamsconveyed through the conduits of the handpiece assembly. Simultaneousdelivery of the various fluids and/or other materials can be performedby combining such fluids in the handpiece assembly.

According to certain embodiments, under a simultaneous delivery scheme,the first, second and/or other fluids are configured to be combinedwithin the main body, at a distal end of the main body, immediatelyupstream of a proximal end of the needle and/or at any other location.In other arrangements, different fluid and/or other material streams aremaintained separate until immediately upstream of the needle. In otherarrangements, the controller includes one or more push buttons, dials,knobs, switches, rollerballs, rollerwheels, rheostats and/or the like.In one embodiment, a button or other controller is configured to controlthe rate of flow of one or more various fluid streams passing throughthe conduits of the handpiece between a no flow condition, a firstflowrate condition and at least a second flowrate condition. The buttonsor other controllers can be configured to provide additional flowratesettings.

In certain embodiments, a method of injecting two or more differentmedicants or other materials contained in nonspecific fluid containersinto a patient using a single needle penetration comprises providing aninjection system. The injection system includes a fluid delivery moduleand a handpiece assembly. According to one embodiment, the fluiddelivery module comprises a first loading area configured to receive afirst container and a second loading area configured to receive a secondcontainer. A fluid delivery module can include additional loading areasto receive additional containers. In some configurations, the firstcontainer comprises a first medicament and the second containercomprises a second medicament. In certain embodiments, the loading areasare configured to securely receive vials or other containers of varioustypes, sizes and shapes. In one embodiment, such containers comprisestandard or non-standard vials. In another embodiment, the vials aresupplied to a clinician or other user of an injection system by amanufacturer or supplier of such medicaments, fluids and/or othermaterials.

According to certain arrangements, the injection system is configured toreceive instructions for delivering the first, second and/or additionalmedicaments. The medicaments can include medications, pharmaceuticalcompositions, drugs, cells, liquid and non-liquid fluids and flowablematerials, nanoparticles, cement, microbeads and/or the like. In oneembodiment, the injection system is configured to simultaneously orsequentially deliver an anesthetic and a steroid for treating a joint.In one embodiment, the fluid delivery module is configured to transferat least a portion of the first medicament from the first container to afirst reservoir of the fluid delivery module and at least a portion ofthe second medicament from the second container to a second reservoir ofthe fluid delivery module.

In certain arrangements, the handpiece assembly is configured to receivea needle. The handpiece assembly is adapted to selectively be in fluidcommunication with the first, second and/or additional reservoirs of thefluid delivery module. In one embodiment, the handpiece assembly ismaneuverable to position the needle within the patient. In anotherarrangement, based at least in part on instructions entered by a user,the injection system is configured to combine the first, second and/oradditional medicaments or other materials prior to their delivery to thepatient. In an alternative embodiment, the injection system isconfigured to administer the first, second and/or additional medicamentsand/or other materials sequentially. The method further comprisesdelivering a volume of the first medicament from the fluid deliverymodule to the patient through the needle of the handpiece assembly basedat least in part on instructions provided to the injection system, anddelivering a volume of the second medicament from the fluid deliverymodule to the patient through the needle of the handpiece assembly basedat least in part on instructions provided to the injection system. Inother embodiments, additional medicaments and/or other materials areselectively delivered from the fluid delivery module to the patientthrough the needle of the handpiece assembly.

In certain arrangements, the handpiece assembly comprises at least onebutton and/or other controller configured to receive instructions fordelivery of the first, second and/or additional medicaments and/or othermaterials. In one embodiment, the fluid delivery module is configured totransfer a predetermined volume of the first medicament and the secondmedicament to the patient. In another arrangement, the fluid deliverymodule comprises a motor to facilitate the delivery of the variousmedicaments and/or other materials to the patient. According to someembodiments, the first medicament comprises an anesthetic and the secondmedicament comprises a steroid.

In another configuration, the fluid delivery module further comprises athird loading area adapted to receive a third container comprising athird medicament or other material. The injection system is configuredto receive instructions for simultaneously or sequentially deliveringthe first, second and third medicaments through the handpiece assemblyto a patient. In certain embodiments, the first, second, third and/oradditional medicaments are delivered either simultaneously orsequentially to a joint or other target anatomical location of apatient. In one embodiment, the fluid delivery module comprises adisplay configured to provide status information about an injectionprocedure, such as, the volume of the first or second medicamentsdelivered through the handpiece assembly or remaining in the first andsecond reservoirs of the fluid delivery module. In some arrangements,one or more of the containers secured to the loading areas of the fluiddelivery module are original manufacturer's vials. In anotherembodiment, the needle is secured to a removable tip of the handpieceassembly. The method can additionally include monitoring a position of adistal end of the needle using an ultrasound, radio frequency,spectroscopy and/or other imaging device or system to accurately locatea target anatomical location (e.g., joint, organ, etc.). In any of theembodiments disclosed herein, the imaging device or system can beconfigured to cooperate with the injection system. In some embodiments,the imaging device or system is in data communication with the handpieceassembly, the fluid delivery module and/or another portion of theinjection system. In some embodiments, one or more buttons or othercontrollers of the handpiece assembly are configured to control one ormore aspects of the imaging device or system (e.g., capturing an image,zoom, etc.).

According to certain embodiments, a method of treating a joint of apatient by selectively delivering at least two different fluids througha single needle penetration includes providing an injection system. Theinjection system comprises a fluid delivery module and a handpieceassembly. In one embodiment, the handpiece assembly comprises adisposable tip with a needle positioned at a distal end of the tip. Incertain arrangements, the handpiece assembly comprises one or morebuttons or other controllers configured to be operated while a usergrasps the handpiece assembly. In some embodiments, a user can handle,manipulate and/or otherwise operate one or more of these buttons orother controllers without having to let go of the handpiece assembly. Incertain configurations, the fluid delivery module comprises a firstloading area adapted to receive a first container and a second loadingarea adapted to receive a second container. The first containercomprises a first fluid, and the second container comprises a secondfluid. A fluid delivery module can include additional loading areas forsecuring additional containers thereto. In some arrangements, the firstfluid or other material is configured to be selectively placed in fluidcommunication with a first reservoir of the fluid delivery module and afirst conduit of the handpiece assembly after the first container issecured to the first loading area. In addition, the second fluid orother material is configured to be selectively placed in fluidcommunication with a second reservoir of the fluid delivery module and asecond conduit of the handpiece assembly after the second container issecured to the second loading area. In one embodiment, the first andsecond conduits are routed through an interior of the handpieceassembly.

In any of the arrangements disclosed herein, the first loading area andsecond loading area are configured to securely receive vials or othercontainers of various types, designs, sizes and shapes. In someembodiments, such containers comprise medications, pharmaceuticalcompositions, drugs, cells, liquid and non-liquid fluids and flowablematerials, nanoparticles, cement, microbeads and/or the like. In oneembodiment, the first fluid comprises an anesthetic and the second fluidcomprises a steroid. In some embodiments, such containers comprisestandard or non-standard vials. In one embodiment, the vials aresupplied, either directly or indirectly, to a clinician or other user ofan injection system by a manufacturer or supplier of such medicaments,fluids and/or other materials. The injection system is configured toreceive instructions for delivering the first, second and/or additionalfluids or other materials to the needle of the handpiece assembly. Inone arrangement, the fluid delivery module is configured tosimultaneously or sequentially transfer a volume of the first fluid, thesecond fluid and/or additional fluids or materials to the needle throughthe first, second and/or additional conduits. In one embodiment, thehandpiece assembly is configured to be in data communication with thefluid delivery module of the injection system. The handpiece assembly ismaneuverable to position the needle within the patient.

According to some arrangements, under a simultaneous injection mode, thefirst, second and/or additional fluids or materials are combined withinthe handpiece assembly at a location upstream of the needle. The methodadditionally comprises delivering a volume of the first fluid from thefluid delivery module to the patient through the needle and through thefirst conduit based at least in part on instructions provided to one ormore of the buttons and/or other controllers of the handpiece assembly.In some embodiments, the method comprises delivering a volume of thesecond fluid from the fluid delivery module to the patient through theneedle and through the second conduit based at least in part oninstructions provided to one or more of the buttons and/or othercontrollers of the handpiece assembly. In one embodiment, the controllercomprises at least one button, knob, dial, switch, lever, rheostat,rollerball, rollerwheel and/or the like. In some embodiments, each ofthe conduits comprises a valve or other device to prevent backflow offluids and/or other materials toward the fluid delivery module. In somearrangements, the method additionally includes monitoring a position ofthe distal end of the needle using an ultrasound, radio frequency,spectroscopy and/or other imaging device or system to accurately locatea joint or other target anatomical area of the patient.

In accordance with other embodiments disclosed in the presentapplication, a system for injecting two, three or more differentmedicaments into a patient through a single needle penetration usingnonspecific fluid containers includes a fluid delivery module and ahandpiece. The fluid delivery module comprises a first loading areaconfigured to secure a first fluid container and a second loading areaconfigured to secure a second fluid container. In some embodiments, thefirst fluid container comprises a first medicament and/or other fluid ormaterial, and the second fluid container comprises a second medicamentand/or other fluid or material. The first loading area and the secondloading area are configured to securely receive containers of varioustypes, sizes and shapes. In some embodiments, such containers comprisestandard or non-standard vials, ampoules and/or the like. In oneembodiment, the vials are supplied to a clinician or other user of aninjection system by a manufacturer or supplier of such medicaments,fluids and/or other materials.

In one embodiment, a disposable needle is configured to removably attachto a distal end of said handpiece. The needle is configured to bepositioned within or near a joint or another portion of a patient'sanatomy. In certain configurations, the fluid delivery module is adaptedto receive instructions for delivering the first and second medicamentsand/or other materials to the needle through an interior portion of thehandpiece. In any of the embodiments disclosed herein, the fluiddelivery module may be adapted to receive and subsequently deliverthrough the handpiece additional medicaments and/or other fluids. Insome arrangements, first and second reservoirs are positioned within aninterior of the fluid delivery module. The fluid delivery module can beconfigured to transfer at least a portion of the first medicament fromthe first fluid container to the first reservoir, and at least a portionof the second medicament from the second fluid container to the secondreservoir. According to some arrangements, a first conduit is configuredto selectively place the handpiece in fluid communication with the firstreservoir of the fluid delivery module and a second conduit isconfigured to selectively place the handpiece in fluid communicationwith the second reservoir of the fluid delivery module. The injectionsystem can include additional conduits for placing the handpiece influid communication with additional reservoirs of the fluid deliverymodule. In one embodiment, the first and second conduits are positionedwithin an interior portion of said handpiece. In certain embodiments,the fluid delivery module is configured to combine the first and secondfluids prior to delivery to the patient. Alternatively, the fluiddelivery module can be configured to administer the first and secondfluids sequentially, depending on the instructions received by the fluiddelivery module, the handpiece and/or any other component or portion ofthe injection system. In one arrangement, each of the conduits comprisesa valve to prevent backflow of fluids toward the fluid delivery module.

According to other embodiments, the handpiece comprises at least onebutton or other controller configured to receive at least oneinstruction related to an injection procedure. In some configurations,the controller comprises at least one button, dial, knob, rheostat,rollerball, rollerwheel, switch and/or the like. In another arrangement,the fluid delivery module comprises a motor to facilitate delivery ofthe first, second and/or additional fluids and/or other materials fromthe reservoirs to the conduits and needle. In one embodiment, the fluiddelivery module additionally comprises a display configured to receiveat least one instruction related to an injection procedure and/orconfigured to provide status information regarding a particularinjection procedure. In some embodiments, the first, second and/oradditional fluids are delivered either simultaneously or sequentially toa joint or other anatomical location of a patient. In certainconfigurations, the status information provided by the display of thefluid delivery module comprises the volume of the first or second fluidsalready delivered through the handpiece assembly or remaining in thefirst and second reservoirs of the fluid delivery module. In otherarrangements, at least one of the first fluid container and the secondfluid container is a nonspecific fluid container. In one embodiment, thefirst and/or second fluid container comprises an original manufacturer'svial (e.g., having a capacity of 5 ml, 10 ml, 50 ml, 100 ml, less than 5ml, greater than 100 ml, ranges between these values and/or the like).In one embodiment, the fluid delivery module is in data communicationwith an ultrasound, radio frequency, spectroscopy and/or other imagingdevice or system configured to locate a targeted joint or otheranatomical location within the patient.

According to certain embodiments, a system for injecting two or moredifferent fluids into a patient using a single needle penetrationincludes a fluid delivery module having a base and a disposable portion.The disposable portion comprises a first loading area and at least asecond loading area, such that each of the loading areas is configuredto securely receive a container thereon. The system further comprises afirst reservoir configured to be placed in fluid communication with aninterior of a first container securely positioned within the firstloading area, and a second reservoir configured to be placed in fluidcommunication with an interior of a second container securely positionedwith the second loading area. In other embodiments, the system comprisesadditional loading areas and corresponding reservoirs to accommodateadditional fluids and/or other materials. In some embodiments, the firstreservoir comprises a first outlet, and the second reservoir comprises asecond outlet. The base of the fluid delivery module comprises a fluidtransfer device adapted to selectively transfer fluids from the firstreservoir to the first outlet and from the second reservoir to thesecond outlet. In one embodiment, the disposable portion is configuredto be removably positioned within a recess of the base.

The injection system additionally includes a handpiece assemblycomprising a handle portion configured to be grasped and manipulated bya user and a tip having at least one internal passage. The handleportion includes an interior and a chamber. The tip additionallyincludes a proximal end and a distal end. In one embodiment, theproximal end of the tip is secured to the handle portion. In anotherarrangement, the internal passage is in fluid communication with thechamber when the tip is secured to the handle portion. The injectionsystem further comprises a needle extending from the distal end of thetip. According to certain configurations, the needle is adapted to bepositioned within an anatomy of a patient. In one embodiment, the systemfurther includes a first conduit placing the first outlet in fluidcommunication with the chamber of the handpiece assembly, and a secondconduit placing the second outlet in fluid communication with thechamber. In certain arrangements, the handpiece assembly comprises atleast one controller configured to at least partially control thedelivery of fluids from at least one of the first and second reservoirsthrough the chamber and to the needle. In some arrangements, fluidsand/or other materials conveyed within the first and second conduits aremaintained separate upstream of the chamber. In some embodiments, eachof the conduits comprises a valve to prevent backflow of said fluidstoward the fluid delivery module.

In certain arrangements, the chamber is located at or near an interfacebetween the handle portion and the tip of the handpiece assembly,upstream of an interface between the handle portion and the tip of thehandpiece assembly or at any other location. In another embodiment, oneor more of the loading areas are configured to receive a nonspecificcontainer. The nonspecific container can include a vial as originallysupplied by a drug manufacturer. In one embodiment, the controllercomprises at least one button, dial, knob, switch, rheostat, lever,rollerball, rollerwheel and/or the like positioned along an exteriorsurface of the handle portion of the handpiece assembly. In oneembodiment, the button comprises a multi-mode and/or multi-depth buttonthat permits a user to vary a flowrate and/or other flow characteristicof the fluids through the handpiece assembly based on the depth or otherposition of the button. In another arrangement, the injection system isoperatively connected to an ultrasound, radio frequency, spectroscopyand/or other imaging device or system configured to assist a user inadvancing the needle to a desired anatomical position within thepatient. In any of the embodiments described or otherwise disclosedherein, one or more of the loading areas is adapted to continuously orintermittently rotate a fluid container positioned thereon in order tomix the contents of a vial or other container positioned within theloading area.

According to certain embodiments disclosed in the present application, amethod of injecting a plurality of fluids into multiple patients usingnonspecific fluid containers includes providing an injection system. Theinjection system includes a fluid delivery module and a handpiece. Thehandpiece comprises a clip, a disposable tip, a reusable core and atleast one button or other controller. In addition, the fluid deliverymodule comprises a first loading area configured to secure a firstcontainer, and a second loading area configured to secure a secondcontainer. In some embodiments, a fluid delivery module can comprisethree or more loading areas to receive additional containers. In someembodiments, the loading areas are configured to securely receive vialsor other containers of various types, designs, shapes and/or sizes. Insome arrangements, the fluid delivery module is configured to receiveinstructions for delivering the first, second and/or additional fluidsor materials for a first patient. Further, the fluid delivery module isconfigured to receive instructions for delivering the first, secondand/or additional fluids or materials for a second patient. In somearrangements, the instructions are modifiable between patients.According to some embodiments, the fluid delivery module is configuredto transfer at least a portion of the first fluid from the firstcontainer to a first reservoir and at least a portion of the secondfluid from the second container to a second reservoir. In oneembodiment, the first and second reservoirs are positioned within aninterior of the fluid delivery module. In certain configurations, adistal end of the disposable tip of the handpiece is adapted to receivea first disposable needle for use with a first patient and a seconddisposable needle for use with a second patient. In one embodiment, thetip is configured to be disposed between patients. The disposable tipcan comprise a valve to prevent reverse flow of the first, second and/oradditional fluids from the needle into the clip of the handpiece. Incertain embodiments, the handpiece is configured to be in fluidcommunication with the first and second reservoirs of the fluid deliverymodule. In certain arrangements, the handpiece is maneuverable toposition the needle within the patient. In one embodiment, the fluiddelivery module and handpiece are configured to combine the first andsecond fluids and/or other materials prior to delivery to the patient.In an alternative embodiment, the fluid delivery module and handpieceare configured to administer the first and second fluids and/or othermaterials sequentially, depending on the instructions received by thefluid delivery module and/or the handpiece.

In some arrangements, the controller of the handpiece comprises at leastone button, knob, dial, switch, rheostat, rollerball, rollerwheel and/orother device configured to receive instructions for controlling at leastone aspect of an injection procedure. According to another embodiment,the fluid delivery module is configured to simultaneously orsequentially transfer a predetermined volume of the first fluid and thesecond fluid to a patient. In one arrangement, the fluid delivery modulecomprises a motor to facilitate the delivery of the fluids to a patient.In other arrangements, the first fluid comprises an anesthetic and thesecond fluid comprises a steroid. In certain configurations, the firstand second fluids are delivered either simultaneously or sequentially toa joint in a patient. In another embodiment, the injection systemfurther comprises a display adapted to provide information regarding thedelivery of the first and second fluids into a patient. In somearrangements, the first and/or the second containers comprise vials assupplied by a drug manufacturer or another nonspecific container.According to other embodiments, the method further includes monitoring aposition of the distal tip of the needle using an ultrasound, radiofrequency, spectroscopy and/or other imaging device or systemoperatively connected to the injection system to accurately locate atarget anatomical location of a patient.

In some embodiments, a method of locating a target anatomical locationof a patient and injecting at least two different medicaments into thetarget anatomical location using a single needle penetration includesproviding an injection system. The injection system comprises a fluiddelivery module and a handpiece having at least one controller. Thefluid delivery module comprises a first loading area configured tosecure a first container and a second loading area configured to securea second container. In other embodiments, a fluid delivery moduleincludes additional loading areas configured to secure additionalcontainers. The first container comprises a first medicament or othermaterial and the second container comprises a second medicament or othermaterial. In one embodiment, the handpiece is configured to be in fluidand data communication with the fluid delivery module. In otherarrangements, the fluid delivery module is configured to selectivelytransfer a portion of the first medicament, the second medicament and/oradditional medicaments or other materials to the handpiece. In oneembodiment, a distal end of said handpiece is configured to receive aneedle. The handpiece is maneuverable to position the needle within thepatient. The method further comprises locating the needle at or near thetarget anatomical location using an imaging device that is in datacommunication with the injection system. In certain embodiments, theinjection system is configured to combine the first and secondmedicaments prior to delivery to the patient. Alternatively, theinjection system is configured to administer the first and secondmedicaments sequentially, depending on the instructions received by theinjection system. In addition, the method comprises delivering a volumeof the first medicament, the second medicament and/or additionalmedicaments or other materials to the patient through the needle basedon instructions received by the injection system.

According to some embodiments, the fluid delivery module is configuredto receive instructions for delivering the first and second medicamentsusing one or more buttons or other controllers positioned on thehandpiece. In one embodiment, the imaging device is operativelyconnected to the injection system using a hardwired or a wirelessconnection. In another configuration, at least one function of theimaging device or system is configured to be selectively controlled byan imaging controller and/or another portion or component of thehandpiece. In some arrangements, the imaging controller of the handpiececomprises a button, dial, switch, knob, rollerball, rollerwheel and/orthe like. In another embodiment, the fluid delivery module comprises amotor to facilitate the delivery of the medicaments and/or othermaterials to the handpiece. In one embodiment, the first and secondmedicaments are delivered either simultaneously or sequentially throughthe handpiece to the patient. In another arrangement, the fluid deliverymodule comprises a display configured to display or otherwise providethe volume of the first and/or second medicaments already delivered tothe patient or remaining within the fluid delivery module or otherstatus information regarding the injection procedure. In one embodiment,the display comprises a touchscreen that is configured to receiveinstructions that help control an injection procedure. In certainembodiments, the first and/or second containers are standard ornon-standard vials supplied by a manufacturer or some other nonspecificcontainer.

According to other embodiments, a system for injecting at least twofluids into an anatomy of a patient includes a handpiece assembly havinga proximal end and a distal end. The handpiece assembly comprises atleast one controller and a needle extending from the distal end of thehandpiece assembly. The system further includes a fluid delivery moduleconfigured to securely receive at least a first container comprising afirst fluid and a second container comprising a second fluid. The fluiddelivery module is configured to selectively transfer a volume of thefirst fluid and/or the second fluid into the patient. According to someembodiments, the system further includes a first conduit configured toconvey the first fluid from the fluid delivery module to the needle anda second conduit configured to convey the second fluid from the fluiddelivery module to the needle. In one embodiment, the first and secondconduits are routed through an interior of the handpiece assembly. Inanother embodiment, the system further includes an imaging deviceoperatively connected to the fluid delivery module, the handpieceassembly and/or any other portion of the injection system. The imagingdevice is configured to help a user advance the needle to a joint oranother target location of the patient's anatomy. In one embodiment, thetransfer of the first, second and/or additional fluids or othermaterials from the fluid delivery module to the needle is at leastpartially controlled using the at least one button or other controllerof the handpiece assembly. In one embodiment, the imaging devicecomprises an ultrasound device.

In several embodiments, the injection systems, devices and methodsdescribed herein are configured to use nonspecific containers. As usedherein, nonspecific containers shall be given its ordinary meaning andshall include, without limitation, containers that vary in size orshape, such as original vial from a drug manufacturer, formulator and/orsupplier. Thus, a nonspecific container may include, without limitation,a standard or non-standard vial or other container that includes one ormore medications, formulations and/or other active or non-activeingredients. The size (e.g., diameter, height, etc.), capacity, shape,material of construction, closure type and/or other details can varybetween different nonspecific containers. For example, the nonspecificcontainer used by a first drug manufacturer or supplier may comprise arelatively small or wide vial, while the nonspecific container used by asecond drug manufacturer or supplier may comprise a relatively large ornarrow vial.

According to one preferred embodiment, an injection system is configuredto selectively deliver two or more medications, formulations and/orother fluids or substances into or near a joint of a patient (or anothertarget anatomical location) using a single needle penetration. Theinjection system includes a fluid delivery module that is adapted toreceive vials or other containers comprising the medicaments and/orother materials to be transferred to the patient through a needlepositioned along the distal end of a downstream handpiece assembly. Insome embodiments, vials or other containers comprising the desiredmedicaments and/or other substances to be used in a particular injectionprocedure are nonspecific containers that are secured to correspondingloading areas of the fluid delivery module or other portion of thesystem with the assistance of adapter.

According to a second preferred embodiment, the injection systemcomprises a handpiece assembly that includes a removable tip, needle andone or more other components or portions. Nonspecific containers (e.g.,vials) containing one, two or more different medicaments and/or othersubstances can be secured onto a fluid delivery module and besubsequently placed in fluid communication with the handpiece assembly.The various types of medicaments and/or other substances can beadministered, in sequential injection procedures, to a plurality ofpatients in a manner that permits the clinician or other user toselectively modify and customize the manner in which the varioussubstances loaded onto the fluid delivery module are administered toeach patient (e.g., modifying the sequence of delivery, the volume orother amount of each medication and/or other substance delivered, etc.).

Such systems, devices and methods can be adapted to allow a clinician toquickly and efficiently treat one or more joints of multiple patients.Moreover, the system permits a clinician to customize the injectionprotocol according to the patient being treated or as otherwise desiredor required. In addition, pain and discomfort to the patient beingtreated is generally reduced by the various embodiments of the injectionsystem disclosed herein. The various medicaments and/or other materialscan be delivered simultaneously or according to a desired sequence. Aclinician or other user can advantageously regulate the delivery of themedicaments and/or other materials into the patient using buttons orother controllers conveniently positioned on the handpiece assembly oranother component of the injection system.

In some arrangements, an injection system is configured to be in datacommunication with and operate concurrently with an ultrasound wandand/or other imaging or intra-anatomical location systems ortechnologies.

According to some embodiments of the present inventions, a system forinjecting two or more fluids into a targeted anatomical locationincludes a handpiece assembly having a proximal end and a distal end, aneedle extending from the distal end of the handpiece assembly, a fluiddelivery module comprising a fluid transfer device and at least twoopenings for inserting fluid containers and a conduit being at leastpartially routed through an interior of the handpiece assembly, theconduit being configured to place the fluid delivery module in fluidcommunication with the needle. According to some embodiments, the fluidtransfer device is configured to transfer fluid from fluid containersplaced within the openings of the fluid delivery module to the targetedanatomical location. In some embodiments, the targeted anatomicallocation comprises a bone, organ, muscle tissue, other tissue, a bodilycavity or any other portion of the anatomy. In other embodiments, theanatomical location comprises an intra-articular space (e.g., ankle,wrist, hand joint, knee, foot joint, spine joint, shoulder joint, anyother joint or space, etc.), bone, muscle tissue, other tissue, an organand/or the like.

According to other embodiments, a method for injecting at least twofluids into a targeted anatomical location comprises inserting a needleinto the targeted anatomical location, the needle being in fluidcommunication with a handpiece assembly and a fluid delivery module,loading at least a first and second fluid into the fluid deliverymodule, instructing the fluid delivery module to deliver the first fluidthrough the handpiece assembly and the needle, instructing the fluiddelivery module to deliver the second fluid through the handpieceassembly and the needle and removing the needle from the anatomicallocation.

In one embodiment, a method for aspirating and injecting fluids into atargeted anatomical location is provided. In one embodiment, the methodcomprises inserting a needle into the targeted anatomical location, theneedle being in fluid communication with a handpiece assembly and afluid delivery module, aspirating a first fluid through the handpieceassembly and the needle, loading at least a second fluid into the fluiddelivery module, delivering the second fluid through the handpieceassembly and the needle, and removing the needle from the anatomicallocation. The first fluid can comprise one or more endogenous and/orexogenous fluids (e.g., naturally occurring fluids, such as synovialfluid, lavage fluids, serum, etc.). The second fluid can comprise one ormore endogenous and/or exogenous fluids. In some embodiments, endogenousfluids include fluids that were pre-existing in the target area prior todelivery of the needle and/or a second fluid. For example, an endogenousfluid may include a diagnostic fluid, a visualization fluid, ananesthetic, or a lavage fluid such as saline, for which aspiration priorto delivery of the exogenous fluid may be desirable or any other fluid.Exogenous fluids include, but are not limited to, medications,pharmaceutical compositions, drugs, cells, liquid and non-liquid fluidsand flowable materials, nanoparticles, cement, microbeads, therapeuticsor diagnostic fluids, imaging fluids, lavage fluids and/or the like, andany combinations thereof. In one embodiment, the system for dualaspiration and fluid delivery comprises a single conduit for bothaspiration and delivery. In another embodiment, the system comprisesseparate aspiration and delivery conduits.

In several embodiments, an imaging device is used to guide the insertionof the needle, the aspiration of fluid, and/or the delivery of fluid tothe target. In one embodiment, the imaging device comprises anultrasound device.

In some embodiments, a method of transferring a volume of fluid to ananatomical location comprises providing a module having an imagingcomponent and an injection component, the injection component beingconfigured to receive and selectively deliver a volume of fluid to aneedle. The method further includes inserting the needle into ananatomy, positioning the needle in a targeted anatomical location usingthe imaging component and injecting a volume of fluid into the targetedanatomical location using the injection component.

BRIEF DESCRIPTION OF THE DRAWINGS

These and other features, aspects and advantages of the presentapplication are described with reference to drawings of certainembodiments, which are intended to illustrate, but not to limit, theinventions. The drawings include one hundred sixty-three (163) figures.It is to be understood that the attached drawings are for the purpose ofillustrating concepts and embodiments of the present invention and maynot be to scale.

FIG. 1 illustrates a schematic of an articular injection systemaccording to one embodiment;

FIG. 2A illustrates a perspective view of an articular injection systemaccording to one embodiment;

FIG. 2B illustrates a rear view of the fluid delivery module of thearticular injection system of FIG. 2A;

FIG. 2C illustrates a perspective view of an articular injection systemaccording to another embodiment;

FIG. 2D illustrates a perspective view of an articular injection systemaccording to another embodiment;

FIG. 2E illustrates a perspective view of an articular injection systemaccording to another embodiment;

FIG. 2F illustrates a perspective view of an articular injection systemaccording to another embodiment;

FIG. 2G illustrates a perspective view of an articular injection systemaccording to another embodiment;

FIG. 3A illustrates a perspective view of a cassette for a fluiddelivery module and configured to receive vials or other containersaccording to one embodiment;

FIG. 3B illustrates the cassette of FIG. 3A with the vials removed fromthe loading areas or nests;

FIG. 3C illustrates a top perspective view of a nest or loading areaconfigured for use with a cassette according to one embodiment;

FIG. 3D illustrates a bottom perspective view of the nest or loadingarea of FIG. 3C;

FIGS. 3E and 3F illustrate different side views of the nest or loadingarea of FIG. 3C;

FIG. 3G illustrates a top view of the nest or loading area of FIG. 3C;

FIG. 3H illustrates a cross-sectional view of the nest or loading areaof FIG. 3C;

FIG. 3I illustrates an exploded perspective view of the nest or loadingarea of FIG. 3C configured to receive a vial or other container;

FIG. 3J illustrates a perspective view of a vial secured within the nestor loading area of FIG. 3I;

FIG. 3K illustrates a top perspective view of a nest or loading area ofa cassette configured to mix the internal contents of a vial or othercontainer secured therein according to one embodiment;

FIG. 3L illustrates an exploded perspective view of the nest or loadingarea of FIG. 3K;

FIG. 3M illustrates an exploded bottom perspective view of the nest orloading area of FIG. 3K;

FIG. 3N illustrates a bottom perspective view of the nest or loadingarea of FIG. 3K;

FIG. 3O illustrates a detailed bottom perspective view of the nest orloading area of FIG. 3K with the clamp hidden for clarity;

FIG. 3P illustrates a detailed bottom perspective view of the nest orloading area of FIG. 3K with the attachment member hidden for clarity;

FIG. 3Q illustrates an exploded perspective view of the nest or loadingarea of FIG. 3K configured to receive a vial or other container;

FIG. 3R illustrates a perspective view of a vial secured within the nestor loading area of FIG. 3K;

FIG. 3S illustrates a perspective view of the nest or loading area ofFIG. 3K mechanically connected to a drive assembly according to oneembodiment;

FIG. 4A illustrates a perspective view of a cassette configured to beinserted within a fluid delivery module according to another embodiment;

FIG. 4B illustrates a perspective view of the cassette of FIG. 4A withthe vials removed from the loading areas or nests;

FIG. 5A illustrates a top perspective view of a nest or loading areaconfigured for use with a cassette according to one embodiment;

FIGS. 5B and 5C illustrate side views of the nest of FIG. 5A;

FIG. 5D illustrates a bottom perspective view of the nest of FIG. 5A;

FIG. 5E illustrates a top view of the nest of FIG. 5A;

FIG. 5F illustrates a cross-sectional view of the nest of FIG. 5A;

FIG. 6 illustrates a perspective view of one embodiment of a cassettewith the loading areas or nests removed;

FIG. 7A illustrates a perspective view of the cassette of FIG. 6 withthe top surface of the cassette housing removed for clarity;

FIG. 7B illustrates a top view of the cassette of FIG. 6 with the topsurface of the cassette housing removed for clarity;

FIG. 7C illustrates a bottom view of a cassette comprising a viewingarea for the delivery line according to one embodiment;

FIG. 7D illustrates a perspective view of a fluid delivery modulecomprising an optical sensor for detecting air or other gases within adelivery line according to one embodiment;

FIG. 8 illustrates a schematic of the transfer of fluids and/or othermaterials between a vial, a manifold and a syringe or other reservoirpositioned within a cassette according to one embodiment;

FIG. 9A illustrates a perspective view of a manifold configured for usein a cassette according to one embodiment;

FIG. 9B illustrates an exploded perspective view of the manifold of FIG.9A and a nest or loading area configured to be positioned thereonaccording to one embodiment;

FIG. 9C illustrates a perspective view of the manifold of FIG. 9B with anest or loading area secured thereto;

FIG. 9D illustrates a cross-sectional view of the manifold and nest orloading area of FIGS. 9B and 9C;

FIG. 9E illustrates an exploded perspective view of the manifold of FIG.9A and a nest or loading area configured to be positioned thereonaccording to another embodiment;

FIG. 9F illustrates a perspective view of the manifold of FIG. 9E with anest or loading area secured thereto;

FIG. 9G illustrates a perspective view of a cassette manifold with anest or loading area positioned thereon according to yet anotherembodiment;

FIG. 10A illustrates a perspective view of a manifold configured for usein a cassette according to another embodiment;

FIG. 10B illustrates a perspective view of the manifold of FIG. 10A witha loading area or nest positioned thereon according to one embodiment;

FIG. 10C illustrates a perspective view of a loading area or nestaccording to one embodiment;

FIG. 11A illustrates a schematic cross-sectional view of the interior ofa manifold according to one embodiment;

FIG. 11B illustrates a schematic cross-sectional view of the manifold ofFIG. 11A when fluids and/or other materials are being transferred from avial to the syringe or other reservoir according to one embodiment;

FIG. 11C illustrates a schematic cross-sectional view of the manifold ofFIG. 11A when fluids and/or other materials are being transferred fromthe syringe or other reservoir to the outlet of the manifold accordingto one embodiment;

FIG. 12A illustrates a top view of the syringes or other reservoirs of acassette in a first position;

FIG. 12B illustrates a top view of the syringes or other reservoirs of acassette in a second position;

FIG. 13A illustrates a perspective view of a motor and accompanyingcomponents of a fluid delivery module according to one embodiment;

FIG. 13B illustrates a side view of the fluid delivery module of FIG.13A;

FIG. 14A illustrates a perspective view of three different vials and anest or loading area of a cassette onto which the vials may be securedaccording to one embodiment;

FIG. 14B illustrates a perspective view of a cassette comprising twodifferent types of nests or loading areas according to one embodiment;

FIG. 15A illustrates a perspective view of an embodiment of a vialadapter and three different vials onto which the adapter may be secured;

FIG. 15B illustrates a perspective view of the vial adapter of FIG. 15A;

FIG. 15C illustrates a top view of the vial adapter of FIG. 15A;

FIG. 15D illustrates a side view of the vial adapter of FIG. 15A;

FIG. 15E illustrates the vial adapter of FIG. 15A secured to the top ofthree different vials;

FIG. 15F illustrates a partial perspective view of three vials securedto corresponding loading areas or nests along the top surface of acassette according to one embodiment;

FIG. 15G illustrates an exploded perspective view of a vial and aloading area or nest into which the vial may be inserted according toone embodiment;

FIG. 15H illustrates a perspective cross-sectional view of the nest ofFIG. 15G;

FIGS. 16A-16D illustrate various views of a vial adapter secured to aloading area or nest according to another embodiment;

FIGS. 17A-17C illustrate various views of a vial adapter secured to aloading area or nest according to another embodiment;

FIGS. 18A-18D illustrate various views of a vial adapter secured to aloading area or nest according to another embodiment;

FIGS. 19A-19C illustrate various perspective views of a vial and a vialadapter comprising an identification flag according to one embodiment;

FIGS. 20A and 20B illustrate perspective views of a vial configured tomaintain its internal contents mixed according to one embodiment;

FIG. 20C illustrates a side view of the vial of FIGS. 20A and 20B;

FIG. 21A illustrates a perspective view of a handpiece assemblyconfigured for use with an articular injection system according to oneembodiment;

FIG. 21B illustrates an exploded perspective view of the handpieceassembly of FIG. 21A;

FIG. 22A illustrates a perspective view of a core of a handpieceassembly according to one embodiment;

FIG. 22B illustrates a side view of the core of FIG. 22A;

FIG. 23A illustrates a perspective view of a clip of a handpieceassembly according to one embodiment;

FIG. 23B illustrates a side view of the clip of FIG. 23A;

FIG. 23C illustrates a top view of the clip of FIG. 23A;

FIG. 23D illustrates a front view of the clip of FIG. 23A;

FIGS. 24A-24C illustrate perspective views of a clip of a handpieceassembly according to another embodiment;

FIG. 25A illustrates an exploded perspective view of a clip of ahandpiece assembly according to another embodiment;

FIG. 25B illustrates a perspective view of the clip of FIG. 25A;

FIGS. 26A-26C illustrate various perspective views of the delivery lineand portions of the clip of FIG. 25A;

FIGS. 27A-27E illustrate cross-sectional views of different embodimentsof multi-lumen delivery lines configured for use with an injectionsystem;

FIG. 28A illustrates a front perspective view of a tip configured foruse in a handpiece assembly according to one embodiment;

FIG. 28B illustrates a side view of the tip of FIG. 28A;

FIG. 28C illustrates a front view of the tip of FIG. 28A;

FIG. 28D illustrates a rear perspective view of the tip of FIG. 28A;

FIG. 28E illustrates a rear view of the tip of FIG. 28A;

FIG. 29A illustrates a front perspective view of a tip configured foruse in a handpiece assembly according to another embodiment;

FIG. 29B illustrates a side view of the tip of FIG. 29A;

FIG. 29C illustrates a front view of the tip of FIG. 29A;

FIG. 29D illustrates a rear perspective view of the tip of FIG. 29A;

FIG. 29E illustrates a rear view of the tip of FIG. 29A;

FIG. 30A illustrates a front perspective view of a tip configured foruse in a handpiece assembly according to another embodiment;

FIG. 30B illustrates a side view of the tip of FIG. 30A;

FIG. 30C illustrates a front view of the tip of FIG. 30A;

FIG. 30D illustrates a rear perspective view of the tip of FIG. 30A;

FIG. 30E illustrates a rear view of the tip of FIG. 30A;

FIG. 31A illustrates a front perspective view of a tip configured foruse in a handpiece assembly according to another embodiment;

FIG. 31B illustrates a side view of the tip of FIG. 31A;

FIG. 31C illustrates a front view of the tip of FIG. 31A;

FIG. 31D illustrates a rear perspective view of the tip of FIG. 31A;

FIG. 31E illustrates a rear view of the tip of FIG. 31A;

FIG. 32A illustrates a front perspective view of a tip configured foruse in a handpiece assembly according to another embodiment;

FIG. 32B illustrates a side view of the tip of FIG. 32A;

FIG. 32C illustrates a front view of the tip of FIG. 32A;

FIG. 32D illustrates a rear perspective view of the tip of FIG. 32A;

FIG. 32E illustrates a rear view of the tip of FIG. 32A;

FIGS. 33A and 33B illustrate different exploded perspective views of tipcomprising a backflow prevention valve according to one embodiment;

FIG. 34 illustrates a cross-sectional view of the tip of FIGS. 33A and33B;

FIG. 35 illustrates a cross-sectional view of a handpiece assemblyaccording to one embodiment;

FIG. 36 illustrates a schematic cross-sectional view of a handpieceassembly according to one embodiment;

FIG. 37 illustrates a schematic cross-sectional view of a handpieceassembly configured to mix various fluid and/or other material streamspassing therethrough according to one embodiment;

FIG. 38A illustrates a schematic cross-sectional view of a tip of ahandpiece assembly configured to mix various fluid and/or other materialstreams passing therethrough according to another embodiment;

FIG. 38B illustrates a schematic cross-sectional view of a needle foruse in a handpiece assembly configured to mix various fluid and/or othermaterial streams passing therethrough according to another embodiment;

FIG. 39 illustrates a perspective view of a handpiece assemblycomprising a site light and an optical ring according to one embodiment;

FIG. 40 illustrates a perspective view of a handpiece assembly accordingto another embodiment;

FIG. 41 illustrates a perspective view of a handpiece assembly accordingto another embodiment;

FIG. 42 illustrates an exploded side view of a handpiece assemblyaccording to another embodiment;

FIGS. 43A and 43B illustrate different perspective views of a handpieceassembly according to another embodiment;

FIG. 44 illustrates a schematic cross-sectional view of a tip configuredto permit aspiration of fluids and/or other materials from an anatomicallocation according to one embodiment;

FIG. 45 illustrates a perspective view of an imaging wand connected tothe fluid delivery module of an injection system according to oneembodiment;

FIG. 46 illustrates a detailed perspective view of the imaging wand ofFIG. 45;

FIG. 47 illustrates a perspective view of a user simultaneouslymanipulating both an imaging wand and a handpiece assembly of aninjection system to treat a patient's foot according to one embodiment;

FIGS. 48A-48D illustrate various screenshots from the visual display ofa fluid delivery module during an injection procedure according to oneembodiment;

FIGS. 49A-49D illustrate various screenshots from the visual display ofa fluid delivery module during an injection procedure according toanother embodiment;

FIG. 50A illustrates a screenshot from the visual display of a fluiddelivery module during an injection procedure according to anotherembodiment;

FIG. 50B illustrates a screenshot from the visual display of a fluiddelivery module during an injection procedure according to anotherembodiment;

FIG. 51 a screenshot from the visual display of a fluid delivery modulecomprising details of both the delivery of materials and imaging duringan injection procedure according to one embodiment;

FIG. 52 illustrates a perspective view of a movable cart configured tosupport an injection system according to one embodiment;

FIG. 53 schematically illustrates a flowchart of one embodiment of asequence for delivering medication to an intra-articular space; and

FIG. 54 schematically illustrates a flowchart of another embodiment of asequence for delivering medication to an intra-articular space.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The discussion and the figures illustrated and referenced hereindescribe various embodiments of an injection system and device, as wellas methods related thereto. A number of these embodiments of theinjection systems, devices and methods are particularly well suited totransfer a volume of one or more fluids to (or from) an intra-articularspace, a bone, an organ or other cavity of the human anatomy (e.g.,foot, ankle, toe, knee, hand, finger, etc.). Such devices, systems andmethods are well-suited for treating osteoarthritis, rheumatoidarthritis, other inflammatory diseases and/or other joint diseases.However, the various devices, systems, methods and other features of theembodiments disclosed herein may be utilized or applied to other typesof apparatuses, systems, procedures and/or methods, whethermedically-related or not.

As discussed in greater detail herein, this application disclosesdevices, systems and methods of locating an intra-articular or otheranatomical space and delivering and/or withdrawing fluids (e.g.,medications, pharmaceutical compositions, drugs, cells, liquid andnon-liquid fluids and flowable materials, nanoparticles, cement,microbeads, etc.) to/from such an intra-articular space (e.g., knee,ankle, elbow, shoulder, wrist, finger, toe, hip, facet joint, vertebra,other spinal joints or spaces, etc.). The devices, systems and methodsdisclosed herein, according to several embodiments, facilitate thedelivery and/or aspiration of two or more different fluids and/or othermaterials to and/or from an intra-articular space or other anatomicallocation by advantageously using a single needle penetration. This canhelp decrease pain and discomfort to patients during the treatment ofvarious joint or other medical disorders. Such systems, devices andmethods can be especially useful for treatment of smaller joints, suchas, for example, thumbs, other fingers, toes and/or the like, which arehighly innervated. In addition, such devices and methods can simplifythe execution of related procedures by physicians and other medicalpersonnel. Accurately locating an intra-articular space is sometimesvery difficult, especially when the targeted joints are relatively small(e.g., fingers, toes, etc.). The devices, systems and methods disclosedherein, according to several embodiments, facilitate the location ofsuch intra-articular or other anatomical spaces.

A. General

FIG. 1 schematically illustrates one embodiment of aninjection/aspiration system 10. As shown, the system 10 can include ahandpiece 200 that comprises a needle 290 positioned along its distalend. In FIG. 1, the distal end of the needle 290 is depicted as havingbeen positioned within a targeted area T of an articular space (e.g.,within or near a joint, synovial space, etc.). In order to reach thetargeted area T, the needle 32 may be routed through skin S and/or oneor more other tissue layers of an anatomy. The targeted space T fortreatment need not be within an articular cavity. For example, such alocation may be on the outside or in the vicinity of a joint, anotherinternal organ or location and/or the like.

In the illustrated embodiment, a delivery line 250 (e.g., multi-lumentubing) or other some other conduit can be used to deliver one or morefluids and/or other materials to and/or from the targeted anatomicalarea T via the handpiece assembly 200. In some embodiments, thematerials delivered to the target anatomical location include one ormore medications, other formulations, other fluids or substances, suchas, for example, pharmaceutical compositions, drugs, cells, liquid andnon-liquid fluids and flowable materials, nanoparticles, cement,microbeads, therapeutics or diagnostic fluids, imaging fluids, lavagefluids, other endogenous or exogenous fluids or materials and/or thelike. As shown, the delivery line 250, and thus, the handpiece assembly200, can be placed in fluid communication with a fluid delivery module100. As discussed in greater detail herein, the fluid delivery module100 can be advantageously configured to accurately deliver one, two ormore different fluids, compositions, other substances or materialsand/or the like to the handpiece assembly 200. In some embodiments, asdescribed in greater detail herein, the fluid delivery module 100 is anelectromechanical software-controlled device that uses motors, pumpsand/or other devices to pull fluids and/or other materials frommulti-dose vials or other containers and push them through the cassettefor delivery through a downstream handpiece assembly. Further, in someembodiments, the needle 290 can be placed in fluid communication with anaspiration source A in order to selectively remove fluids and/or othermaterials or substances from a targeted anatomical location. The terms“handpiece,” “handpiece assembly” and “handpiece device” are usedinterchangeably herein.

According to some embodiments, the aspiration source A comprises asyringe, a pump or any other device or system that is configured tocreate a negative or vacuum pressure in the needle 290. As illustratedand discussed herein with reference to other arrangements, theaspiration source A can be connected to the handpiece assembly 200.Alternatively, the aspiration source A can be a separate item from thehandpiece assembly 200 and/or any other component of the system 10. Forexample, the aspiration source A can be as simple as a disposablesyringe that is configured to be placed in fluid communication with theneedle 290 by removing all or a portion of the handpiece assembly 200.

With continued reference to the schematic embodiment of FIG. 1, thefluid delivery module 100 can advantageously include a pump or otherfluid transfer device (e.g., syringes operated by a motor, actuatorand/or other mechanical device) to transfer one or more medications,fluids and/or other substances or materials to the targeted anatomicallocation T (e.g., toe, knee, other intra-articular space, etc.). In someembodiments, such fluids, substances and/or materials can be included invials 400 or other containers that may be conveniently secured to thefluid delivery module 100.

According to other embodiments, the fluid transfer device comprises aperistaltic pump, a syringe pump, a gear pump, a bladder pump, adiaphragm pump, a metering pump and/or any other type of pump. Such afluid transfer device can be adapted to deliver solids, non-Newtonianfluids, other non-flowable materials and/or the like (e.g., cement,microbeads, etc.) to a desired anatomical location.

The general arrangement of the systems, systems and methods illustratedand discussed herein permits one or more fluids, substances or othermaterials to be delivered to and/or removed from an intra-articularspace with a single needle penetration. Therefore, pain and/ordiscomfort to a patient can be advantageously reduced. This may beespecially important when transferring fluids to and/or from theintra-articular space of a small joint, such as, for example, a toe,thumb, other finger and/or the like. Such small joints are typicallyhighly innervated, making them more sensitive to pain. Further, thecomplexity and other difficulties associated with executing suchprocedures can be reduced for physicians or other clinicians. Inaddition, as discussed in greater detail herein, such systems (orequivalents or variations thereof) can be configured to easily andaccurately deliver a desired quantity of medications and/or otherfluids, substances or materials, or a combination thereof, to a desiredanatomical location.

According to some embodiments, an anesthetic is initially delivered intothe patient using the injection system. For example, a desired volume ofLidocaine and/or any other anesthetic can be selectively deliveredwithin the anatomy to reduce the pain and discomfort to the patient. Insome arrangements, such an anesthetic is delivered while the needle atthe distal end of a handpiece assembly is advanced through the skin andother anatomical tissues and portions. Alternatively, the anesthetic canbe delivered once the needle has been accurately positioned at or nearthe target anatomical location (e.g., joint, organ, etc.). Further, inseveral embodiments, the delivery of an anesthetic is followed by thedelivery of a second anesthetic (e.g., a slow-acting anesthetic), asteroid (e.g., Depo-Medrol®) and/or any other material (e.g., hyaluronicacid, saline, pain-relieving medications, pharmaceutical compositions,other medications or drugs, cells, liquid and non-liquid fluids andflowable materials, nanoparticles, cement, microbeads, etc.) as desiredor required. For example, a physician or other clinician may haveparticular injection protocols or schemes for treating certain diseases,conditions and/or patients. As discussed in greater detail herein, thevarious medications, formulations and/or other fluids and/or othermaterials can be delivered into a patient simultaneously orsequentially.

FIG. 2A illustrates one embodiment of an injection system 10 configuredto deliver one or more medications, formulations and/or other fluids ormaterials to a joint or other target location within the anatomy. Asshown, the system 10 can include a fluid delivery module 100, one ormore handpiece assemblies 200 and a cassette 300 or cartridge, which insome arrangements, is configured to be removably secured to the fluiddelivery module 100. As discussed in greater detail herein, theintra-articular delivery system 10 can be configured so that one or morevials 400A, 400B, 400C or other containers comprising medications and/orother fluids, substances or materials can be easily loaded onto thecassette 300 or other portion of the fluid delivery module 100. In someembodiments, a cassette or other portion of the fluid delivery module isconfigured to receive off-the-shelf medication and/or fluid packages inmulti-dose vials. Further, in certain arrangements, a cassette or otherportion of the fluid delivery module is configured to receive one ormore non-specific fluid containers.

Such medications, fluids, materials and/or substances can be accuratelyand conveniently administered to a targeted anatomical location (e.g., ajoint), through a needle (not shown) located at the distal end of thehandpiece assembly 200. As discussed in greater detail herein (see FIGS.21A-44), the handpiece assembly 200 can be adapted to be in fluidcommunication with the fluids and/or other materials contained withinthe vials 400A, 400B, 400C or other containers. In addition, in somearrangements, the system 10 may be used to selectively aspirate fluidsand/or other substances from an intra-articular space or other portionof the anatomy, either in lieu of or in addition to delivering one ormore fluids and/or other substances within the anatomy.

The needle positioned at the distal end of the handpiece assembly can beadvantageously configured to be delivered through the skin and othertissues of a patient so as to adequately reach the targeted joint (e.g.,toe, ankle, knee, spine, hand, finger, neck, etc.) or other anatomicallocation (e.g., organ). In several embodiments, the needle has a gaugeof 18G-30G and a length of about 0.5 to 5.0 inches (e.g., 1.0 to 1.5inches). In other arrangements, the gauge, length and/or other detailsof the needle can be greater or smaller than the range indicated herein,as desired or required by a particular application. Further, the needlecan comprise surgical-grade stainless steel and/or any other suitablematerials (e.g., other metals, alloys, etc.).

B. Fluid Delivery Module

With continued reference to FIG. 2A, the intra-articular delivery system10 can include a display 130 along one or more of its outer surfaces. Asdiscussed in greater detail herein, the display 130 can provide variousdata and other information to the user. In some embodiments, the fluiddelivery module 100 comprises a data input device (e.g., keyboard,keypad, dials, buttons, etc.) to permit a user to enter data and/orother information regarding a particular procedure. For example, in onearrangement, the display 130 comprises a touchscreen configured to bothprovide information to and receive information from a user.

As shown in FIG. 2A, the fluid delivery module 100 can include one ormore charging receptacles 116 or other docking stations, each of whichmay be sized, shaped and otherwise configured to receive a handpieceassembly 200. In some embodiments, a docking station 116 is adapted torecharge one or more batteries of the handpiece assembly 200. Forexample, as discussed in greater detail herein, such a station can beconfigured to inductively or otherwise recharge a core portion of ahandpiece assembly 200 when the handpiece assembly 200 is not in use.

In addition, the fluid delivery module 100 can include one or more othercomponents or features to enhance the function, aesthetic appearanceand/or other aspect of the system 10. For example, in FIG. 2A, the fluiddelivery module 100 comprises a recess or groove 114 along its upper endthat facilitates positioning the cassette 300 into and/or out of the topof the module 100. The quantity, location, shape, size and/or details ofsuch recesses or grooves 114 can be different than depicted in FIG. 2A.Moreover, an intra-articular injection system 10 can include one or moreother components or features, as desired or required by a particularapplication.

As shown in the embodiment of FIG. 2A, the housing 110 or outer chassisof the fluid delivery module 100 can include generally rounded corners.Alternatively, however, the housing 110 can comprise any other shape,size, configuration and/or feature. Further, the fluid delivery module100 can include generally smooth or glossy surfaces that are configuredto withstand frequent cleaning. In some arrangements, the fluid deliverymodule 100 is waterproof or water-resistant or substantially waterproofor water-resistant. Smooth exterior surfaces of the module 100 canfacilitate cleaning and prevent residual contamination from remaining onthe housing. Further, the fluid delivery module 100 can be configured tomaintain vials and/or other containers secured thereon at a particularthermal setting or temperature range. For example, the module 100 caninclude a temperature control system (e.g., cooling/heating device,temperature sensor, regulator, etc.) that permits the module 100 tomaintain a pharmaceutical or other material to be delivered into apatient within a desired temperature range. This can be especiallyimportant for the delivery of formulations or other substances thatdegrade or are otherwise transformed when not temperature-controlled(e.g., refrigerated, heated, etc.).

With continued reference to FIG. 2A, a bottom portion of the housing 110or chassis can include a plurality of feet 112 or other support members.In some embodiments, the feet 112 are configured to maintain a desiredclearance between the housing 110 and the surface on which the fluiddelivery module 100 rests. In addition, the feet 112 can facilitate inthe handling (e.g., lifting, repositioning, etc.) of the module 100.Further, the feet or other support members 112 can comprise a non-slipor non-skid surface or texture to prevent the undesirable movement ofthe module 100 during transport or use.

In some embodiments, as illustrated in FIG. 2A, a touchscreen display130 of a fluid delivery module 100 is generally rectangular. In certainarrangements, the display 130 comprises a flat panel touchscreen havinga 7-inch color TFT LCD. The resolution of the display 130 can be 800×600with a total of 480,000 pixels and a brightness rating of 300 cd/m³. Inaddition, the touchscreen display 130 can use restive technology forsending touch input. In some embodiments, the touchscreen is compatiblewith and/or without the use of gloves. However, the type, size,resolution, brightness, compatibility and/or other details about thedisplay 130 can vary, as desired or required. For example, thetouchscreen display 130 can comprise a 16 to 9 aspect ratio. However,the type, shape, size, aspect ratio, resolution and/or othercharacteristics of the display 130 can vary, as desired or required. Asdiscussed in greater detail herein, the touchscreen display 130 can beadapted to identify one or more characteristics regarding thepharmaceutical or other container (e.g., syringe, vial, etc.) secured tothe module 100. In addition, the touchscreen display 130 can beconfigured to display status information, patient information (e.g.,name, vital signs, known allergies, etc.), imaging information,injection procedure programming and/or status information and/or anyother information. Further, the touchscreen display 130 and/or anotherdata entry device can permit a physician, other clinician or other userto control the operation of the procedure (e.g., verify patient, verifyfluids or other materials to be delivered, locate target joint, start,stop, reduce/increase flowrate or other rate of delivery, etc.) and/orto enter other data within the system 10.

According to some arrangements, the touchscreen display 130 isconfigured to illustrate text and/or images (e.g., icons). The use oficons can facilitate the physician or other user in performing therequired injection and/or aspiration procedure. For example, thetouchscreen display 130 can be configured to display a list of variousbody parts (e.g., foot, hand, spine, knee, other body parts or organs,etc.) into which a desired injection is to occur. Once a user selectsthe general anatomical area targeted by the procedure, the touchscreendisplay 130 can provide a more detailed selection list of availabletarget sites within that general area. For example, if a foot isselected, the touchscreen display 130 can provide a more detailed listof joints associated with the foot (e.g., ankle, toe, etc.).Alternatively, the display 130 can provide a list of various injectionprotocols from which to choose. In other embodiments, the touchscreendisplay 130 can include “UP” and “DOWN” softkeys (FIGS. 48A-48D and49A-49D) arrows or any other icons, text and/or other images thatfacilitate the user during the execution of the corresponding procedure.

In some embodiments, the selected icon or other portion of the display130 can be configured to change color, shade, shape and/or the like whena user selects it. Further, the fluid delivery module 100 can beconfigured to provide audible verification that a selection was made(e.g., tone, beep, etc.). It will be appreciated that a touchscreendisplay 130 and/or any other component of the fluid delivery module 100can include one or more other features, as required or desired by aparticular application. As discussed, an injection system can alsoinclude a voice command/notification system that permits a user toreceive audile updates from the system (e.g., volume dispensed, volumeremaining, etc.) and/or to control the operation of the system usingaudible instructions (e.g., “START,” “STOP,” “DECREASE DELIVERY RATE,”“INCREASE DELIVERY RATE,” “PAUSE,” “TERMINATE” and/or the like). Theabove disclosure regarding the display 130 (e.g., touchscreen device)and other features can be applied to any other embodiment of a fluiddelivery module disclosed herein or equivalents thereof.

Another embodiment of an intra-articular injection system 10A isillustrated in FIG. 2C. The depicted injection system 10A is similar tothe one discussed herein with reference to FIG. 2A. However, the 100A ofthe injection system 10A illustrated in FIG. 2C comprises a lesscontoured shape that the one illustrated in FIG. 2A. As shown, thehandpiece assembly 200A can be placed in fluid communication with thevials 400A, 400B, 400C loaded onto the cassette 300A via tubing 250A orother conduit.

Additional embodiments of fluid delivery modules 100B-100E and cassettes300B-300E configured to be positioned therein for use withintra-articular injection systems 10B-10E are illustrated in FIGS.2D-2G. As shown in these alternative arrangements, the fluid deliverymodules and/or the cassette positioned therein can have a more verticalorientation than in the embodiments illustrated in FIGS. 2 and 2C. As aresult, the vials (not shown) containing the medications, formulations,other fluids, substances or materials and/or the like can be secured todifferent portions of the fluid delivery module and/or cassette.

With continued reference to FIGS. 2D-2G, the position of the display130B-130E and/or any other component or feature of the respectiveinjection system 10B-10E can be varied, as desired or required.

The fluid delivery module 100 and/or any other components of theinjection system 10 can be powered by one or more power sources. Forexample, in some embodiments, the fluid delivery module 100 comprises anAC power cord or other connection. In such arrangements, the ACtransformer can be situated either within or outside of the modulehousing 110. As illustrated in FIG. 2B, a power port 111A positionedalong the rear or side of the housing 110 can be configured to receive apower cord or other power supply connection. In other embodiments, thefluid delivery module 510 is powered by one or more batteries (e.g.,rechargeable lithium batteries, etc.), either in addition to or in lieuof the AC power supply. This can provide an extra measure of protectionto ensure that an injection procedure is not interrupted because of apower outage. In addition, the use of batteries and an external AC powertransformer can generally increase the portability of the system andhelp reduce its overall size. However, other types of devices and/ormethods can be used to provide electrical power to the fluid deliverymodule 110 and/or other components of the injection system 10. Asillustrated in FIG. 2B, the fluid delivery module 100 can include one ormore other ports or slots 111B, 113 configured to operatively connectthe module 100 to one or more other devices, processors and/or the like(e.g., ultrasound or other imaging device, network, personal computer,etc.). Such ports or slots can be standard (e.g., USB, mini-B, parallel,etc.) or non-standard, as desired or required. For example, the depictedfluid delivery module 100 comprises a single USB port 113.

Further, a fluid delivery module 100 can comprise one or more memory,communication and/or other types of slots. Thus, the module 100 can beupgraded with additional programs, functions and/or other capabilities.In some embodiments, as discussed, a fluid delivery module 100 comprisesa USB 113 or other port that is configured to communicate with apersonal computer or other device (e.g., the hospital's computingnetwork, a monitoring device, another medical device, etc.). In yetother arrangements, the fluid delivery module 100 includes a wirelesscommunication system (e.g., modem, Wi-Fi, RFID, Bluetooth, etc.) thatpermits it to communicate with other components of the injection system(e.g., handpiece assembly) and/or one or more other computing systems ordevices. These types of communication devices can permit a user totransfer data (e.g., continuously or intermittently) to and/or from themodule 100, as desired or required. For example, new software orsoftware patches can be periodically installed onto the module 100,either automatically or manually.

The fluid control module 100 can comprise and/or be in communicationwith a processor, control device and/or the like. This can permit themodule 100 to adequately process data and control the operation of thevarious components of the fluid injection/aspiration system (e.g., thecore or other portions of the handpiece assembly, fluid transfer device,display, etc.). In some embodiments, the required processor and/orcontrol unit are included within the housing 112 of the module 110.Alternatively, such components can be external to the module 100. Insuch arrangements, the fluid delivery module 100 can be placed in datacommunication with an exterior processor and/or control unit using oneor more hardwired and/or wireless communications.

Cassette

FIG. 3A illustrates one embodiment of a cassette 300 configured to bepositioned within a fluid delivery module 100 (FIG. 2A). As discussedand illustrated in greater detail herein, the cassette 300 can comprisean outer housing 302 that is configured to enclose one or more internalcomponents (e.g., manifolds, syringes or other reservoirs, etc.). Thedepicted cassette 300 has a generally rectangular shape. In severalarrangements, the approximate dimensions of the cassette 300 are 9.7inches long, 6.5 inches wide and 1.6 inches tall. In other embodiments,the cassette is permanently secured to the fluid delivery module 100 orforms a generally unitary structure with the fluid delivery module.Further, in some embodiments, the cassette 300 and/or any of itscomponents or portions comprise one or more plastic, other polymeric,metal and/or other synthetic or natural materials, or combinations ofsame. However, the shape, size, materials of construction and/or othercharacteristics of the cassette 300 can vary, as desired or required fora particular application or use. In addition, the cassette 300 cancomprise one or more finger wells 304, grooves or recessed areas thatfacilitate placement of the cassette 300 into and/or out of thecorresponding area of a fluid delivery module 100.

As discussed in greater detail herein, the cassette 300 can be adisposable item that is replaced periodically (e.g., once, twice or moreoften per day). In other embodiments, the cassette 300 may be configuredto be replaced more or less often than indicated above, as desired orrequired. Alternatively, the cassette 300 can be removed and replacedwhen one or more medications or other fluids or substances beingdelivered using the intra-articular injection system are changed. Thiscan help prevent cross-contamination between different types ofsubstances, different dosages of substances and/or the like. Accordingto some arrangements, the cassette 300 is replaced along with one ormore other components of the injection system, such as, for example, theclip of the handpiece assembly and the delivery line (e.g., multi-lumentubing) that places the handpiece assembly in fluid communication withthe cassette 300.

In the embodiment depicted in FIG. 3A, up to three vials 400A-400C orother containers may be secured to receiving sites 310, 312, 314 locatedalong the top surface of the cassette 300. In some embodiments, eachreceiving site comprises a nest or loading area that is adapted toaccept a standard or non-standard vial or other container. The cassette300 can include more or fewer receiving sites 310, 312, 314, as desiredor required. In addition, the location, spacing and other details of thereceiving sites 310, 312, 314 can be different than illustrated in FIG.3A. As discussed in greater detail herein, once the vials 400A-400C orother containers are secured to the cassette 300, the injection systemcan be configured to transfer the contents of such vials or othercontainers within the fluid delivery module 100 and accurately deliverthe interior contents of one or more of such vials 400A-400C to atargeted anatomical location in a precise and accurate manner. In theillustrated embodiment, larger vials 400A, 400B (e.g., 50 ml capacity)are secured to two receiving sites of the cassette, while a smaller vial400C (e.g., 5 ml capacity) is secured to one receiving site. Forexample, the smaller vial 400C can be secured to a nest or loading areaof the cassette 300 that is configured to keep the internal contents ofsuch vial mixed. As discussed in greater detail herein, such mixing maybe desired or required for certain medicants or other materials, suchas, for example, steroids or other solutions or mixtures that have atendency to settle or that require mixing. In certain arrangements, thereceiving sites of the cassette are configured to receive a variety ofdifferent vials or other containers.

FIG. 3B illustrates the embodiment of the cassette of FIG. 3A with novials or other containers secured to the receiving sites 310, 312, 314.In the depicted arrangement, each receiving site 310, 312, 314 comprisesa nest 370, loading area or other component or portion to which a vialmay be secured. The loading area 370 or nest can be a separate memberthat is joined to the housing 302 or other portion of the cassette 300using one or more attachment devices or methods. Alternatively, theloading area 370 or nest (or an equivalent thereof) can form a unitarystructure with the cassette 300 (e.g., the loading area or nest can bemolded or manufactured as a single piece with the housing 302 or otherportion of the cassette 300 or fluid delivery module). As used herein,the term loading area is a broad term and includes, without limitation,a nest, docketing port or station, an opening, a slot and/or any othercomponent, area or portion configured to receive a vial or othercontainer. Accordingly, the terms loading area, nest and the like areused interchangeably herein.

With continued reference to FIG. 3B, the nests or loading areas 370 canbe sized, shaped and otherwise adapted to securely receive the topportions (e.g., neck areas) of various vials or other containers.Accordingly, the clinician or other user of the injection system caneasily, quickly and conveniently position multi-dose vials (e.g.,standard or non-standard vials as supplied to the clinician) onto thefluid delivery module. Thus, the need to transfer liquids from suchvials to other reservoirs or containers of an injection system can beadvantageously eliminated. As discussed in greater detail herein, thiscan provide several benefits and other advantages. For example,potentially time-consuming efforts to transfer the medicaments, fluidsand/or other substances to the injection system can be reduced oreliminated. Relatedly, the use of such nests or other loading areas canmake the injection procedure safer, as the likelihood of contaminationof the various fluids or other substances (e.g., with the outsideenvironment, between the various medicament streams, etc.) can bereduced. Further, the amount of wasted fluids or other materials thatwould otherwise remain as unused residual within the vials or othercontainers that are supplied to the user can be advantageously reducedor eliminated.

FIG. 3C illustrates one embodiment of a nest 370 or loading area whichis configured to be secured to a cassette and which is adapted toreceive a vial or other container therein. As discussed herein withreference to FIGS. 3A and 3B, the nest 370 or loading area and thecassette 300 can be separate items that are attached to one anotherusing one or more connection devices or methods. Alternatively, thecassette 300 and the nest 370 can be integrally formed with one another.For example, in the embodiment of FIG. 3C, the lower portion of theloading area or nest 370 comprises four tabs 384 that are adapted tosnap or otherwise connect to the cassette 300 and/or a component locatedon or within the cassette. In other arrangements, a nest can includemore or fewer that four tabs 384 as desired or required. Further, one ormore other connection devices (e.g., threads, screws, other mechanicalfasteners, rivets, etc.) or methods (e.g., gluing, welding, etc.) can beused to attach the nest 370 to the cassette 300, either in lieu of or inaddition to the tabs 384. As shown, each tab 384 can include aprotruding portion 396 adapted to engage a corresponding portion orcomponent of the cassette (e.g., manifold, housing, etc.) to which itattaches. Other views of the loading area 370 of FIG. 3C are illustratedin FIGS. 3D-3H.

With continued reference to FIGS. 3C-3H, the nest 370 or loading areacan include a cylindrical portion 372 that generally defines an interiorregion into which a vial or other container may be positioned. In theillustrated arrangement, the cylindrical portion 372 comprises two wallsthat are positioned opposite of one another. Alternatively, the portionof the nest 370 that defines an interior region for accepting a vial orother container can include more or fewer walls or other members orfeatures. In addition, such a portion 372 can have a different size,shape (e.g., non-cylindrical, rectangular, etc.) and/or othercharacteristics, as desired or required. For example, according toseveral arrangements, the diameter or other cross-sectional dimension ofthe cylindrical portion 372 is approximately between 0.4 and 0.7 inches(e.g., 0.4 inches, 0.5 inches, 0.6 inches, 0.7 inches, etc.) or valuesbelow, above or between such values. However, in other embodiments, thesize, shape and/or other details regarding the loading area or nest canvary, as desired or required.

According to certain embodiments, the nest 370 or loading area comprisestwo wings 376 or other flexible members that are configured toreleasably secure a vial or other container within the nest. As shown inFIGS. 3C-3H, each wing 376 can include a vertical portion 392 which isgenerally parallel to the adjacent walls of the cylindrical portion 372and which helps to define the interior region of the nest 370 or loadingarea. These vertical portions 392 of the wings 376 and the cylindricalportions can be secured to a base 394 of the nest 370. The tabs 384 orother members used to connect the nest 370 to the cassette 300 can alsoextend from the base 394. In other embodiments, the nest 370 includesmore or fewer than two wings 376 or other flexible members. Further, theshape, size, design and/or other characteristics of the wings 376 can bedifferent than discussed and illustrated herein.

An upper portion of each wing 376 can include an inwardly-facing lockingmember 377 which is configured to maintain the neck 406 or other closure410 of a vial 400 or other container within the interior region of thenest 370 or loading area (FIG. 3I). In some arrangements, as depicted inFIGS. 3C-3E, the locking member 377 comprises one or more slopedportions. In addition, an upper portion of each wing 376 can include ahandle member 378 which is used to selectively move the wing 376 awayfrom the interior region of the nest 370 or loading area. According tosome arrangements, the handle member 378 comprises a generallyhorizontal rectangular portion which is adjacent to or near the lockingmember 377. Alternatively, the shape, size, location and/or otherdetails of the handle member 378 can vary, as desired or required.

As illustrated in FIGS. 3C, 3D, 3E, 3G and 3H, a main needle 332 and avent needle 380 can be positioned within an interior region of theloading area or nest 370. Thus, when a vial or other container issecured therein, the main needle 332 and the vent needle 380 can helpplace the internal contents of the vial (e.g., medicament, other fluid,other material or substance, etc.) in fluid communication with one ormore subcomponents of the cassette 300 (e.g., manifold, syringe or otherreservoir, etc.) and other components of the injection system. Accordingto some arrangements, the main needle 332 and the vent needle 380 areapproximately 0.5-1.5 inches long and have a gauge of approximately15-30. The vent needle 380 and the main needle 332 can have differentlengths, gauges and/or other properties from one another. However, thegauge, length, location and/or other characteristics of the main needle332 and/or the vent needle 380 can be different than disclosed herein,as desired or required for a particular application or use. In certainarrangements, the needles 332, 380 comprise surgical-grade stainlesssteel and/or any other materials suitable for insertion into a patient(e.g., other metals, alloys, etc.).

The main needle 332 and/or the vent needle 380 can be attached to thenest 370. Alternatively, one or both of the needles 332, 380 can beattached to the cassette housing 302 or another portion of the cassette300. In the embodiment illustrated in FIGS. 3C-3H, the main needle 332extends below the bottom of the cylindrical portion 372 of the loadingarea or nest 370, thereby enabling the needle 332 to place anothercomponent (e.g., manifold) of the cassette 300 in fluid communicationwith the interior of the respective vial or other container secured tothe nest 370. As best depicted in the cross-sectional view of FIG. 3H,the vent needle 380 can terminate at a vent area 382 that allows thevent needle 380 to be in fluid communication with the surroundingatmosphere. This permits ambient air to enter into the vial or othercontainer to displace the volume of fluids and/or other substances whichare removed from the vial or other container. Accordingly, the emptyingof the vials or other containers secured to the cassettes 300 isadvantageously facilitated.

According to some embodiments, the nests 370 or loading areas aresupplied with protective covers or other members (not shown) that areconfigured to be removably positioned within the interior region definedby the walls of the cylindrical portion 372. Such covers or othermembers can help shield the needles 332, 380 and other sterile portionsof the nest 370 from the environment (e.g., against contamination). Inaddition, the covers can help protect the clinician or other useragainst injury (e.g., accidental punctures) that may be caused by theprotruding needles.

FIG. 3I illustrates a perspective view of a vial 400 being oriented in amanner for insertion into a nest 370 or loading area. In order to securea vial 400 or other container to the nest 370, a clinician or other usercan align the closure 410 or other portion of the vial's neck 406 withthe interior region defined by the walls of the cylindrical portion 372and the wings 376. In some embodiments, during this process, the closure410 or other leading surface of the vial 400 will first contact thesloped or slanted surfaces of the locking member 377. As the vial 400 isurged downwardly (e.g., into the interior region of the nest 370), theclosure 410 or other leading surface of the vial 400 can slide againstthe locking members 377 of wings 376, thereby causing the wings 376 toseparate outwardly from each other. If the vial 400 is urged far enoughinto the interior area, the ends of the locking members 377 (e.g., theslanted surfaces) can move above the closure 410 of the vial so that thewings 376 resiliently move inwardly (e.g., toward each other) within theneck 406 of the vial 400. Thus, in some embodiments, the vial 400 orother container cannot be removed from the interior region of the nest370 because the locking members 377 of the wings 376 engage the adjacentsurfaces of the closure 410 or other portion of the vial 400.Consequently, as illustrated in FIG. 3J, the vial 400 or other containercan “snap” into the nest 370 or loading area and can be removably lockedor otherwise secured thereto.

As discussed, the nest 370 or loading area can be adapted to receivevials or other containers of different shapes, sizes, designs,configurations and/or the like. According to some embodiments, theloading area 370 can accommodate vials (e.g., standard or non-standardvials having a capacity of 5 ml, 10 ml, 50 ml, 100 ml or the like) asprovided, either directly or indirectly, to the clinician or other userby a pharmaceutical manufacturer or supplier. In other arrangements, thenest 370 or loading area is configured to receive other types of vialsor containers. As discussed, once a vial 400 or other container ispositioned within the loading area 370, a main needle 332 and a ventneedle 380 can penetrate a septum or other portion of the vial's closure410 to access the interior of such vial 400. Thus, the internal contentsof the vial 400 (e.g., medicaments, other fluids or materials, etc.) canbe placed in fluid communication with other portions of the cassette andfluid delivery module.

In order to remove a vial 400 or other container from the nest 370, theclinician or other user can pull the handles 378 of the wings 376 awayfrom each other so the locking members 377 can move far enough apart topermit the closure 410 of the vial to be lifted out of the interiorregion. In some embodiments, the handles 378 are configured so that theymay be grasped and separated using a single hand. This can permit a userto conveniently separate the wings 376 of the loading area 370 with onehand while removing the vial 400 or other container with the other. Inother arrangements, one or more different ways of securing a vial to anest 370 or loading area or removing it therefrom can be used.

As discussed, one or more of the cassette's nests or loading areas canbe configured to continuously or intermittently mix the contents (e.g.,steroids) of a vial or other container secured thereto. In somearrangements, it is desirable or necessary to maintain the internalcontents of a vial or other container mixed while such vial or othercontainer is positioned on the cassette. For example, certain types offormulations that include a relatively high solids concentration mayneed to be mixed to ensure that a consistent and homogeneous dose isprovided to the patient during an injection procedure. Other types offluids, materials and/or other mixtures may require to be continuouslyor intermittently mixed to problems other than settling and/or tootherwise remain effective before being injected into a patient. Thus,one or more devices or methods of agitating the internal contents of avial or other container can be advantageously provided.

One embodiment of such a nest 370A or loading area is illustrated inFIGS. 3K-3P. As shown, the nest 370A can comprise an attachment member1210, a gear member 1230 and a clamp 1250. In other embodiments, thenest or loading area can include more, fewer and/or differentsubcomponents or portions. The various subcomponents and/or portions ofthe loading area 370A can be adapted to secure to one another, and insome arrangements, rotate or otherwise move relative to one another. Asdiscussed in greater detail herein, a separate motor or other mechanicaldevice can be used to move the gear and/or any other portion of the nest370 or loading area in order to selectively rotate a vial or othercontainer secured thereto. Accordingly, a desired amount of mixing canbe accomplished for medicaments, other fluids and/or other substancescontained within such a vial. This may be particularly important withvials that contain a relatively high concentration of solids, fluids orother materials that are prone to settling, stratification or some othernon-homogenous phenomenon and/or materials that otherwise require mixing(e.g., steroids).

With reference to the exploded perspective view of FIG. 3L, theattachment member 1210 can be similar to the lower portion of the nest370 of FIG. 3C in that it is configured to secure to a cassette oranother portion of a fluid delivery module. For example, as shown, theattachment member 1210 can include a base 1214 and a plurality of tabs1218 extending therefrom. As discussed, the tabs 1218 can be used toengage a corresponding feature or area of a cassette (e.g., manifold,housing, etc.) and/or another portion of a fluid delivery module.Further, the attachment member 1210 can include a plurality ofengagement members 1220 along an upper portion of the base 1214. In somearrangements, these engagement members 1220 comprise flanges 1224 thatgenerally extend outwardly, toward the outer perimeter of the nest 370A.As described in greater detail herein, these engagement members 1220 canbe sized, shaped and otherwise configured to mate with and permitrotation relative to corresponding members or features of the gearmember 1230 and the clamp 1250.

With continued reference to FIG. 3L, the gear member 1230 can include ahelical gear 1232 having a plurality of gear teeth 1234 along itsperiphery. In addition, the gear member 1230 can be configured to attachto a clamp 1250. For example, in the depicted embodiment, the clamp 1250comprises two attachment members 1280 that generally extend downwardly.As shown, each attachment member 1280 can include a securement portion1282 that is configured to securely fit within a corresponding opening1235 of the gear member 1230 (FIG. 3M). FIG. 3P illustrates a bottomperspective view of the nest 370A with the attachment member hidden inorder to reveal the interaction between the clamp 1250 and the gearmember 1230 when these components are secured to each other. Thus, thesecurement portion 1282 of each attachment member 1280 can be movedsufficiently far within the corresponding opening 1235 so that thesecurement portion 1282 moves underneath the bottom surface of the gear1234. According to some arrangements, the clamp 1250 is connected to thegear member 1230 in a manner that prevents or substantially prevents anyrelative movement (e.g., separation, rotation, etc.) between the twocomponents.

With continued reference to FIG. 3M, the bottom of both the clamp 1250and the gear member 1230 can comprise one or more engagement members1270, 1236 that are sized, shaped and otherwise configured to complementand rotate relative to the engagement members 1220 of the attachmentmember 1210. For example, in the depicted arrangement, each engagementmember 1270, 1236 of the clamp 1250 and the gear member 1230 includes aninwardly-facing flange 1272, 1238 that fits underneath the flanges 1220of the attachment member 1210 when the nest 370A or loading area isproperly assembled. Thus, the inwardly-facing engagement members 1270,1236 of the clamp 1250 and gear member 1230 can be allowed to rotaterelative to the outwardly-facing engagement members 1220 of theattachment member 1210. However, the respective tabs 1272, 1238, 1224can be configured to prevent separation of the gear member 1230 from theadjacent attachment member 1210.

According to some embodiments, when the clamp 1250 is adequatelyconnected to the gear member 1230, the engagement members 1270 of theclamp 1250 are configured to fit within corresponding slots or otheropenings of the gear member 1230. Thus, as illustrated in theperspective views of FIGS. 3N-3P, the engagement members 1270, 1236 ofthe two components can form an inwardly-facing flange that is adapted tomate with and rotate relative to the outwardly-facing flanges 1224 ofthe attachment member 1210. As a result, the clamp 1250 (and a vial orother container positioned therein) can be continuously orintermittently rotated relative to the attachment member 1210 and thecassette to which it is secured in order to provide the necessary ordesired mixing or agitation to the medicaments, other fluid or substanceand/or other contents of the vial.

As illustrated in FIGS. 3Q and 3R, a vial 400 or other container can besecured within an interior region of the nest's clamp 1250 in a similarmanner as described herein with reference to the nest 370 of FIG. 3C-3J.For example, clamp 1250 can include one or more walls 1254 or otherportions that generally define a cylindrical region. In somearrangements, such a cylindrical region is sized, shaped and otherwiseconfigured to accommodate vials or other containers having a variety ofsizes, shapes, capacities, designs and/or other characteristics. Inaddition, as discussed with reference to FIGS. 3C-3J, the clamp 1250 caninclude oppositely-oriented wings 1260 that are configured toresiliently move outwardly when a vial or other container is insertedwithin the nest 370A or loading area. Accordingly, inwardly-facinglocking members 1264 of the wings 1260 can releasably engage the closureor other portion of a vial when such a vial is inserted sufficientlydeep into the interior region of the nest 370A or loading area. In someembodiments, the locking members 1264 comprise slanted surfaces thatforce the wings 1260 to move outwardly when a vial is being positionedwithin the nest 370A. In order to remove the vial 400 or other containerform the nest 370A, the handles 1268 can be moved outwardly (e.g., awayfrom each other) so that the closure 410 of the vial 400 can disengagefrom the adjacent surfaces of the wings' locking members 1264.

With reference to FIG. 3S, the gear member 1230 of the nest 370A orloading area can be selectively rotated by mating the gear 1232 with acomplementary gear 1292 or other portion of a drive assembly 1290. Thegear 1292 can be mechanically connected to a motor (not shown) or othermechanical device configured to rotate the drive gear and othermechanically-coupled members or components (e.g., shaft 1292). Accordingto some embodiments, such a motor or other mechanical device ispositioned within or on the fluid delivery module of an injectionsystem. The gear 1292, shaft 1294 and other portions of the driveassembly 1290 can be removed in order to facilitate replacement of acassette. For example, in one embodiment, the shaft 1294 of the driveassembly 1290 is routed through an opening of the cassette 300.Therefore, the gear 1292, the shaft 1294, the bolt or other coupling1296 that ensures that the gear 1292 remains adequately secured to theshaft and/or any other components or portions of the drive assembly 1290can be removed in order to allow the user to remove or replace acassette 300. In other embodiments, the drive assembly 1290 ispositioned or is otherwise configured to permit replacement of acassette 300 without having to remove or otherwise manipulate the driveassembly 1290.

According to certain arrangements, the speed, frequency and otherrotation details of the gear member 1230 (and thus the vial or othercontainer secured within the nest 370A) can be varied. For example, therotational speed can be automatically selected based on the type ofmedicaments, other fluids and/or other materials contained within avial. Alternatively, the clinician or other used can manually set and/oradjust such rotational details, either before or during a procedure(e.g., by instructions provided to the touchscreen display of the fluiddelivery module, by manipulating one or more controllers of thehandpiece assembly and/or the like).

In any of the arrangements disclosed herein, or variations thereof, thenests or loading areas and/or other components of the cassette compriseone or more plastic, metal and/or other rigid, semi-rigid and/orflexible materials. The materials can be selected to withstand thevarious elements and potentially damaging conditions to which they maybecome exposed, including, but not limited to, forces, moments,temperature and pH variations, other physical or chemical factors and/orthe like.

FIGS. 4A and 4B illustrate another embodiment of a cassette 300′configured to be positioned within a fluid delivery module, such as theone discussed herein with reference to FIG. 2A. In general, the depictedarrangement is similar to the cassette 300 of FIG. 3A in that itincludes three receiving areas 310′, 312′, 314′, each of which isadapted to accept a vial or other container. However, the receivingareas of the cassette shown in FIG. 4A include different types of nests370′ or loading areas than those of FIG. 3A. As shown, the nests 370′ orloading areas of FIGS. 4A and 4B are adapted to engage and secure tovial adapters 440 that are positioned over the closure portions (e.g.,neck, top, etc.) of the vials.

Detailed views of one embodiment of a loading area or nest 370′configured to be used in the cassette of FIGS. 4A and 4B are illustratedin FIGS. 5A-5F. As shown, the nest 370′ can include a generallycylindrical portion 372′ that is shaped, sized and otherwise configuredto receive at least a portion of a vial or other container (e.g., theclosure, neck, top, etc.). For example, according to severalarrangements, the diameter of the cylindrical portion 372′ isapproximately 0.5 to 0.7 inches. However, in other embodiments, thesize, shape and/or other details regarding the loading area or nest canvary, as desired or required. As discussed in greater detail herein, amain needle 332 and a vent needle 380 can be positioned within theinterior of the cylindrical portion 372′ of the loading area or nest370′. Thus, when a vial or other container is secured to the nest, themain needle 332 and the vent needle 380 can help place the internalcontents of the vial (e.g., medication, other fluid, other material orsubstance, etc.) in fluid communication with one or more subcomponentsof the cassette 300 (e.g., syringe or other reservoir) and othercomponents of the articular injection system. According to somearrangements, the main needle 332 is approximately 0.540 to 0.625 incheslong and has a gauge of 22, and the vent needle 380 is approximately0.950 long and has a gauge of 22. However, the gauge, length and/orother characteristics of the main needle 332 and/or the vent needle 380can be different than disclosed herein, as desired or required for aparticular application or use. For example, in some embodiments, themain needle 332 is about 0.1 to 2 inches long and has a gauge from about15 to about 30, and the vent needle 380 is about 0.1 to 2 inches longand has a gauge from about 15 to about 30. The needles 332, 380 cancomprise surgical-grade stainless steel and/or any other suitablematerials (e.g., other metals, alloys, etc.).

With continued reference to the embodiment illustrated in FIGS. 5A-5F,the lower portion of the loading area or nest 370′ comprises four tabs384′ that are adapted to snap or otherwise connect to the cassette 300and/or a component located on or within the cassette. In otherarrangements, a nest can include more or fewer that four tabs 384′ asdesired or required. Further, one or more other connection devices(e.g., threads, screws, other mechanical fasteners, rivets, etc.) ormethods (e.g., gluing, welding, etc.) can be used to attach the nest370′ to the cassette 300, either in lieu of or in addition to the tabs384′.

As shown, the loading area or nest 370 can include one or more wings376′ or similar members positioned adjacent to the cylindrical portion372′. In the depicted arrangement, the wings 376′ comprise a pluralityof teeth 378′ or other engagement members along a portion of their outersurface. As discussed and illustrated in greater detail herein, suchwings 376′ and teeth 378′ positioned thereon can be used to releasablymaintain the position of a vial or other container relative to the nest370′. In addition, the loading area or nest can comprise one or moreposts 374′ or other positioning members that are used to properly alignthe vial and any item or component (e.g., adapter) attached thereto inrelation to the cassette 300. One or more other features or devices canbe used to secure a vial to and/or align a vial with the cassette 300.

The main needle 332 and/or the vent needle 380 can be attached to thenest 370′. Alternatively, one or both of the needles 332, 380 can beattached to the housing 302 or another portion of the cassette 300. Inthe embodiment illustrated in FIGS. 5C, 5D and 5F, the main needle 332extends below the bottom of the cylindrical portion 372′ of the loadingarea or nest 370′, thereby enabling the needle 332 to place anothercomponent (e.g., manifold) of the cassette 300 in fluid communicationwith the interior of the respective vial or other container secured ontothe nest 370′. As best depicted in the cross-sectional view of FIG. 5F,the vent needle 380 can terminate at a vent area 382′ that allows thevent needle 380 to be in fluid communication with ambient air. Thispermits air to enter into the vial or other container to displace thevolume of fluids and/or other substances which are removed from the vialor other container. Accordingly, the emptying of the vials and othercontainers secured to the cassettes 300 is advantageously facilitated.

FIG. 6 illustrates the cassette 300 of FIG. 3A or 4A with the respectiveloading areas or nests 370, 370A, 370′ removed. In the depictedembodiment, each of the main needles 332 that extends through theinterior of the cylindrical portion of the respective nest 370, 370A,370′ (see FIGS. 3C-3R and 5A-5F) is attached to a manifold 330positioned within the interior of the cassette 300. In somearrangements, the cassette is adapted to receive one or more of thevarious nest configurations disclosed herein or variations thereof. Forexample, as illustrated in FIGS. 3A and 3B, a cassette 300 can includetwo nests 370 of the same type and one nest 370A configured to providemixing to the internal contents of a vial or other container securedtherein. Additional details regarding the manifold 330 and othercomponents and features of the cassette 300 are provided herein withreference to FIGS. 7A-12B.

In FIGS. 7A and 7B, the top portion of a cassette housing 302 has beenremoved to reveal the interior of the cassette 300. As shown, thecassette 300 can comprise one manifold 330 and one syringe 360 for eachreceiving station 310, 312, 314, 310′, 312′, 314′ (FIGS. 3A and 4A). Inthe illustrated embodiment, the interior of the cassette 300 includesgrooves and other recesses into which the various components of thecassette 300 can be positioned. For example, one or more interiorsurfaces (e.g., bottom, top, etc) of the cassette 300 can compriserectangular recesses 326 and/or other features that are sized, shapedand otherwise configured to receive the manifolds 330. In addition, thecassette 300 can include one or more other positioning baffles 328 orother members that are configured to support and securely maintain theposition of the syringes 360 and/or any other component of the cassette300. In the depicted arrangement, the positioning baffles 328 includeslots that are sized, sized and otherwise adapted to receive one or moreportions of the syringes 360. It will be appreciated that in otherembodiments the manifolds 330, syringes 360 and/or any other componentor feature can be secured to the cassette 300 using one or more otherattachment method or device (e.g., adhesives, fasteners, etc.), eitherin addition to or in lieu of the recesses 326, positioning baffles 328and other features illustrated in FIG. 7A.

With continued reference to FIGS. 7A and 7B, each syringe 360 positionedwithin the cassette 300 can include an inner plunger 364 that isslidably movable within an outer barrel 362. In some embodiments, suchsyringes 360 are standard plastic, sterile syringes. Alternatively, thesyringes 360 can be non-standard syringes that are specifically designedfor use with a cassette 300. In addition, the syringes 360 can compriseone or more other materials (e.g., glass), as desired or required. Asdiscussed and illustrated in greater detail herein, movement of theinner plunger 364 away from the outer barrel 362 (e.g., in a directiongenerally away from the manifold 330), can cause fluids and/or othermaterials from the respective vial 400A-400C (FIGS. 3A and 4A) to bedrawn into the interior of the syringe 360. Once one or more fluidsand/or other materials have been loaded into the syringe 360, a steppermotor, a pump, another mechanical or pneumatic device and/or the likecan be used to selectively move the inner plunger 364 toward themanifold 330, thereby delivering a desired volume of such fluids and/orother materials to the handpiece assembly of the articular injectionsystem. As discussed in greater detail herein, a stepper motor or otherdevice can be used to initially move the inner plunger 364 away from themanifold 330 in order to transfer fluids and/or other materials from avial into the corresponding syringe 360 or other reservoir.

According to some arrangements, in part for patient safety, the pump orother fluid transfer device is configured to accurately measure andregulate the flowrate and/or pressure of a medication, fluid and/orother material being delivered to a patient. Thus, the system cancomprise pressure and/or flow measurement devices (e.g., pressuretransducers, flowmeters, etc.). Pressure sensing devices can be used toensure that the pressure or vacuum created by the discharge of themedication, fluid or other material within the anatomy does not exceed aparticular threshold level. This can help prevent or reduce thelikelihood of damage occurring to the patient being treated using theinjection/aspiration system. Such an internal force measurement systemcan be configured to automatically shut off the pump or other transferdevice when the discharge pressure exceeds a maximum level (e.g., 3 psi.levels lower or higher than 3 psi, etc.). In other arrangements, thefluid delivery module and/or any other portion of the injection system(e.g., handpiece assembly) can include a visual and/or audible alarm orother similar feature to alert the user than a threshold pressure hasbeen attained, either in lieu of or in addition to any automaticshut-off mechanism. It will be appreciated that such safety features canbe included in any of the embodiments of the modules or systemsdisclosed herein.

In the illustrated arrangement, the cassette 300 includes a plurality ofslots 324 or other openings adjacent to the syringe plunger 364 (e.g.,generally along the normal range of slidable motion of the plunger 364relative to the barrel 362). Thus, an arm, lever or other actuationdevice mechanically or operatively connected to a motor or othermovement device can be used to slidably move the inner plunger 364relative to the outer barrel 362 of the syringe 360 to selectivelytransfer fluids and/or other materials into or out of the syringes 360.

With continued reference to the cassette 300 illustrated in FIG. 7B, asa fluid and/or other material is selectively expelled through a syringe360, it travels through an interior portion of the downstream manifold330 to an outlet coupling 390. In some embodiments, the outlet coupling390 places the syringe 360 and manifold 330 in fluid communication withan outlet conduit 251A-251C. Collectively, the different conduits251A-251C can comprise a delivery line 250 that is configured to deliverfluids and/or other materials from the cassette 300 to a handpieceassembly for injection into a targeted anatomical location (e.g., ajoint). As shown in FIG. 7B, the delivery line 250 can be routed out ofthe interior of the cassette 300 through an opening 252 located alongthe outer housing.

According to some embodiments, the injection system can be adapted todetect the presence of air or other gases within any of the conduitsthat place the cassette or another portion of the fluid delivery modulein fluid communication with a downstream handpiece assembly. This canhelp reduce or eliminate the likelihood of a potentially dangerous,harmful, painful or otherwise unintended air infusion into a patient'sanatomy. Thus, as illustrated in FIG. 7C, a cassette 300 can include aviewable area 306 along one or more portions of its housing 302 thatallows for visual inspection of the various conduits configured toconvey fluids and/or other materials from the manifolds of the cassetteto the handpiece assembly. The viewable area 306 can include a separateinspection strip 307A-307C for each conduit of the delivery line.

In some arrangements, the viewing area 306 is positioned along a bottomsurface of the cassette housing 302 and is configured to align with anoptical sensor 308 housed on or within the fluid delivery module 100(FIG. 7D). Thus, portions of the conduits that are immediately adjacentto the viewable area 306 can be at least partially transparent ortranslucent to permit the optical sensor 308 to detect thecharacteristics of the fluids and/or other materials passingtherethrough. Accordingly, air or other gas bubbles within the conduitscan be detected by the optical sensor 308 as they travel past theinspection strips 307A-307C of the cassette 300. Once one or morebubbles are detected, the injection system can be configured toterminate the injection procedure, provide a warning to the clinician orother user and/or take any other action. According to some embodiments,the air or other gas bubbles are purged from the system before theinjection procedure can be resumed. For example, a predetermined volumeof fluid and/or other substance being conveyed in the conduits where airor gas was detected can be wasted or otherwise sacrificed to ensure thatit has been eliminated from the system.

In certain arrangements, the optical sensor 308 is configured to detectthe presence of air or other gas bubbles within a conduit by monitoringthe refractive index of the conduits, as air and other gases refractlight differently than the liquids and/or solids being transferredwithin the delivery line. The fluid delivery module 100 and/or any otherportion of the injection system can include one or more other devices ormethods for detecting the presence of undesirable air or other gaseswithin the delivery line, either in addition to or in lieu of theoptical sensor system described and illustrated herein. For example, oneor more mechanical sensors, pressure sensors, ultrasonic sensors,capacitance sensors, or combinations thereof, can be used in addition toor instead of optical sensors.

FIG. 8 illustrates one embodiment of a schematic generally representingthe movement of fluids and/or other materials within and between variouscomponents of an articular injection system, such as, for example, avial 400, a manifold 330, a syringe 360, other components or portions ofa cassette 300, a handpiece assembly 200 and/or the like. As shown, oncea vial 400 is properly secured to a receiving site of a cassette 300, amain needle 332 can be configured to extend into the interior of thevial 400. In some embodiments, the closure 410 of vial 400 comprises aseptum or other pierceable membrane or member (not shown) through whichthe needle 332 may pass. As a result, the medication, other fluid and/orother materials contained within the vial 400 can be advantageouslyplaced in fluid communication with the main needle 332.

Next, in order to load the syringe 360 with the internal contents of thevial 400, the inner plunger of the syringe 360 can be retracted relativeto the outer barrel. As discussed in greater detail herein, a motor,actuator or other device within the fluid delivery module can be used toselectively move the inner plunger relative to the outer barrel.Accordingly, the suction created within the syringe 360 can cause thefluid and/or other materials contained within the vial 400 to be drawninto the syringe 360 in the direction generally represented by arrow Ain FIG. 8. Thus, fluids and/or other materials can be delivered from thevial 400 to the syringe 360 through a valve 350 or other flow-controldevice. In some embodiments, the valve 350 comprises a combinationduckbill-umbrella valve that is configured to permit flow in thedirection generally represented by arrow A when suction is createdwithin the syringe 360. This can help ensure that no fluids or othermaterials are inadvertently transferred toward the delivery line 250 andhandpiece assembly located downstream of the manifold 330.Alternatively, one or more other types of valves and/or flow schemes maybe used.

With continued reference to the schematic of FIG. 8, once fluids and/orother materials have been transferred from the vial 400 to the syringe360, the fluid delivery module can be used to selectively transfer adesired volume or amount of such fluids and/or other materials to adownstream handpiece assembly 200. In one embodiment, the syringe 360 isconfigured to draw out the entire contents of the vial 400 during theinitial loading stage. Alternatively, only a portion of the internalcontents of a vial 400 or other container can be transferred to thesyringe 360 before such contents are selectively delivered to thehandpiece assembly 200 and/or other downstream components of theinjection system.

Once a syringe 360 has been properly loaded with fluids and/or othermaterials, a desired volume of such fluids and/or other materials can beselectively transferred through the manifold 330. The transfer of fluidsand/or materials from the syringe 360 to downstream components of theinjection system (e.g., delivery line 250, handpiece assembly 200, etc.)can be accomplished with the help of a mechanical, hydraulic and/orother type of device. For example, a stepper motor or other actuator canbe configured to operate the syringe 360 (e.g., move the inner plungerrelative to the outer barrel) in order to selectively transfer fluidsand/or other materials from the syringe 360 toward the manifold 330. Inthe depicted embodiment, fluids and/or other materials are transferredfrom the syringe toward the delivery line 250 in a direction generallyrepresented by arrow B. Thus, fluids and/or other materials can berouted through the same valve 350 that is used to control the transferof fluids and/or other materials from the vial 400 (or other container)to the syringe 360. For example, the valve 350 or other flow controldevice can be configured to allow flow in a direction generallyrepresented by arrow B when a sufficiently high positive pressure iscreated within the syringe 360. This can be accomplished by using aspecially-designed valve 350 (e.g., a combination duckbill-umbrellavalve) that regulates flow of fluids and/or other materials in certaindesired directions depending on the type of forces and pressures exertedwithin the syringe 360 (e.g., negative or suction, positive, etc.).Additional details regarding flow through such a combinationduckbill-umbrella valve 350 are provided herein in reference to thediscussion of FIGS. 11A-11C.

In other embodiments, the quantity, type, orientation, generalconfiguration and other details of the passages, valves and/or othercomponents of the manifold 330 and/or other components of a cassette 300can vary, as desired or required. Further, the general manner in whichthe syringes 360 are filled with the internal contents of the vials orother containers can be different than discussed and illustrated herein.For example, in some embodiments, the contents of the vials 400 cangravity flow into desired portion (e.g., syringe 360, other reservoir,etc.) of the cassette 300. In other arrangements, the vials 400 or othercontainers can be directly secured within an interior of the cassette300 or other portion of the fluid delivery module. Moreover, a cassette300 need not include a syringe 360, a manifold 330 and/or any othercomponent or feature illustrated and discussed herein. Other methods ordevices can be utilized to load a fluid and/or other material intocassette 300 for later delivery to a downstream handpiece assembly 200or other component of an articular injection system.

With continued reference to the schematic of FIG. 8, a fluid or othermaterial exiting through an outlet fitting 390 of the manifold 330 canbe routed to a conduit 251. Conduits 251 from two or more differentmanifolds 330 can comprise a delivery line 250, which, as discussed ingreater detail herein, can advantageously place the cassette 300 influid communication with a handpiece assembly 200.

FIG. 9A illustrates one embodiment of a manifold 330 for use in acassette 300. As shown, the manifold 330 can include an inlet 340 intowhich the distal end of a syringe or other reservoir attaches. In someembodiments, the inlet 340 (and/or the outlet) of the manifold 330 isadapted to receive a standard or non-standard fitting or correspondingmating portion (e.g., a luer, a coupling 390, etc.). As discussed, anoutlet coupling 390 can be used to place the manifold 330 in fluidcommunication with a downstream conduit 251. In some embodiments, a mainneedle 332 is used to place one or more internal fluid passages of themanifold 330 in fluid communication with a vial or other container thatmay be removably secured to a cassette. The main needle 332 can beattached to the manifold 330. Alternatively, the main needle 332 can beattached to a loading area or nest 370, 370′, 370A or any othercomponent or portion of the cassette 300 or fluid delivery module.

One embodiment of a loading area or nest 370 secured to the manifold 330of FIG. 9A is illustrated in FIGS. 9B and 9C. As discussed herein withreference to FIGS. 3C-3H, the nest 370 can include a plurality of tabs384 or other members that are adapted to snap onto or otherwise engageone or more portions of the manifold 330 or cassette. In the illustratedarrangement, the ends of such tabs 384 are shown resiliently engaged toone or more features (e.g., ribs 331) located along an exterior surfaceof the manifold 330. For clarity, the top surface of the cassettehousing has been omitted in FIGS. 9B and 9C. In other embodiments,however, the nest 370 can be secured to the manifold 330 and/or otherportion of the cassette 300 using one or more other devices or methods,either in lieu of or in addition to the snaps 384.

FIG. 9D illustrates a cross-sectional view of a vial 400 positionedwithin a nest 370 or loading area of FIGS. 9B and 9C. As shown, theclosure 410 of the vial 400 is secured underneath the locking member 377of each wing 376 of the nest 370. Accordingly, a main needle 332 and avent needle 380 have penetrated a septum 414 or other pierceablemembrane of the closure 410, thereby accessing the interior of the vial400. Thus, the main needle 332 can advantageously place the fluidsand/or other materials contained within the vial 400 in fluidcommunication with the manifold 330 to which the nest 370 is attached.In addition, as illustrated in the perspective views of FIGS. 9E and 9F,a nest 370A or loading area configured to rotate a vial or othercontainer positioned therein (see FIGS. 3K-3S) may be secured to acassette manifold 330.

A different embodiment of a nest 370′ connected to a manifold 330 of acassette is illustrated in FIG. 9G. The depicted nest 370′ is similar tothe one discussed herein with reference to FIGS. 5A-5F. Therefore, avial adapter (not shown) may need to be positioned on a container (e.g.,vial) before such a container is secured to the nest 370′. As with otherarrangements disclosed herein, the nest 370′ of FIG. 9G can include aplurality of tabs 384 or other members that are adapted to snap onto orotherwise engage one or more portions of the manifold 330 or cassette(e.g., ribs 331).

Another embodiment of a manifold 330A adapted for use with a cassette orother portion of a fluid delivery module is illustrated in FIG. 10A. Asshown, an upper portion of the manifold 330A can include a projectingportion 385 through which the main needle 332A and/or the vent needle380A may extend. The projecting portion 385 can include a generallycylindrical shape or any other shape, as desired or required. In theillustrated embodiment, the projecting portion 385 comprises a ring 386that extends at least partially around the outside of the projectingportion 385. The ring 386, other raised feature and/or the like can besized, shaped and otherwise configured to mate with a correspondingportion of a loading area or nest onto which a vial may be secured. Forexample, in some embodiments, the top of a manifold 330A or a topportion of the cassette housing is configured to securely receive a nestthereon using a turn-lock connection or some other attachment device ormethod.

FIG. 10B illustrates one embodiment of the manifold 330A of FIG. 10Asecured to a loading area or nest 370A. In addition, FIG. 10Cillustrates a bottom perspective view of the nest 370A of FIG. 10B. Asshown, a bottom portion 384A of the nest 370A can be configured toengage the ring 386 or other feature of the projecting portion 385 ofthe manifold 330A. For example, the bottom portion 384A can comprise agenerally cylindrical section having a pair of tabs 381 that extendinwardly. Such tabs 381 can be sized, shaped and otherwise adapted to bepositioned below and rotatably slide relative to the ring 386 or otherfeature of the manifold 330A. In one embodiment, the tabs 381 arealigned with and inserted through corresponding notches 383 along theprojecting portion 385 of the manifold 330A. Then, the nest 370A can berotated (e.g., quarter revolution, half revolution, etc.) relative tothe manifold 330A in order to move tabs 381 below the ring 386 or otherexterior feature of the projecting portion 385. As a result, the nest370A and the manifold 330A can be secured to each other. Alternatively,one or more other methods of releasably joining a nest to a manifold canbe used. Moreover, a nest and an adjacent manifold can be permanentlyattached to each other, as desired or required by a particularapplication or use.

As illustrated in FIG. 10C, the main needle 332 can extend from thebottom of the loading area or nest 370A so that it may be advantageouslyplaced in fluid communication with one or more passages, valves or otherfluid components of the manifold 330A. The size, shape, general designand/or other details of the nest 370A, the manifold 330A and/or anyother component or feature of the cassette or articular injection systemcan be varied as desired or required.

The schematic cross-sectional view of FIG. 1A illustrates the internalconfiguration of a manifold 330 according to one embodiment. Asdiscussed, a main needle 332 can be used to place the manifold 330 influid communication with a vial or other container (not shown)positioned within a loading area, nest or other receiving area of acassette or other portion of the fluid delivery module. In FIG. 11A, themain needle 332 attaches to an upper portion of the manifold 330 andterminates at a void 334 located within an interior of the manifold 330.In some arrangements, the void 334 comprises an annular area thatcompletely or partially surrounds a valve 350 (e.g., combinationduckbill-umbrella valve). However, the type, shape, size and/or otherdetails of the void 334, valve 350, general fluid scheme and othercomponents or features of the manifold can be different than illustratedand discussed herein, as desired or required.

With continued reference to FIG. 11A, the manifold 330 can be configuredso that the void 334 is selectively placed in fluid communication withan upstream cavity 346 to permit fluids and/or other materials to beadvantageously transferred from the main needle 332 to the inlet 340 ofthe manifold 330. As discussed, such a step can be performed when thereis a desire to fill the syringe 360 (FIGS. 7A and 7B) or other reservoirof the cassette that is positioned upstream of the inlet 340.Consequently, some or all of the contents (e.g., medication,formulation, other fluids or substances, etc.) of a vial or othercontainer with which the main needle 332 is in fluid communication canbe delivered to the syringe or other reservoir positioned within thecassette or other portion of the fluid delivery module.

FIG. 11B schematically illustrates the manifold of FIG. 11A while fluidsand/or other materials are being transferred from the main needle 332 tothe inlet 340 of the manifold 330. As discussed herein with reference toFIGS. 7A and 7B, a suction force can be applied to the upstream cavity346 of the manifold (e.g., by moving the inner plunger away from theouter barrel of a syringe). Thus, if the tip of the syringe is attachedto, inserted into or otherwise placed in fluid communication with theinlet 340 of the manifold 330, a corresponding suction force can becreated within the upstream cavity 346.

As shown in FIG. 11B, if such a vacuum force is sufficiently high, theumbrella portion 356 of the combination valve 350 can move away from thevoid 334, thereby allowing fluids and/or other materials to be deliveredfrom the main needle 332 to the upstream cavity 346 in a directiongenerally represented by arrows A₁ and A₂ in FIG. 11B. From the upstreamcavity 346, the fluids and/or other contents of a vial can be routed toa syringe (not shown) or other reservoir attached to or placed in fluidcommunication with the inlet 340 of the manifold 330. For example, inthe depicted embodiment, fluids and/or other materials can be deliveredinto a syringe that is positioned within the inlet nozzle 342 in adirection generally represented by arrow A₃. Once the suction force isterminated or sufficiently reduced (e.g., by stopping the movement ofthe inner plunger relative to the outer barrel of the syringe), theumbrella portion 356 of the valve 350 will seat against the void 334,thereby preventing the flow of materials from the main needle 332 to theupstream cavity 346.

FIG. 11C schematically illustrates the manifold 3300 of FIG. 11A asfluids and/or other materials are being delivered through thecombination duckbill-umbrella valve 350 to the downstream cavity 348. Asshown, if sufficient positive backpressure is applied to the upstreamcavity 348, fluids and/or other materials may be transferred through theduckbill portion 352 of the combination valve 350 in a directiongenerally represented by arrow B. As discussed, in some embodiments, thenecessary backpressure may be generated by moving the inner plungerwithin the outer barrel of the syringe positioned along the inlet 340 ofthe manifold 330 in order to expel the fluids and/or other materialscontained within the syringe. As a result, such fluids and/or othermaterials can pass through the duckbill portion 352 of the valve 350 tothe downstream cavity 348. At the same time, the positive backpressurewithin the upstream cavity 348 can cause the umbrella portion 356 of thevalve to seat against the void 334, thereby ensuring that no fluidsand/or other materials enter the void 334 and the main needle 332.Consequently, as discussed herein with reference to FIGS. 7B and 8, adesired volume of fluids and/or other materials exiting the manifold 330can be delivered to a handpiece assembly through an outlet coupling 390and a delivery line 250.

FIGS. 12A and 12B schematically illustrate the filling of syringes 360positioned within a cassette 300. In FIG. 12A, each of the threesyringes 360 is empty or substantially empty, as the inner plunger 364is positioned completely within the outer barrel 362. As the innerplungers 364 are drawn rearwardly away from the respective manifolds 330(e.g., in a direction generally represented by arrow A), fluids F and/orother substances from the vials or other containers secured to thecassette (e.g., nests, loading areas, other receiving areas, etc.) canbe drawn through the manifolds 330 and into the syringes 360. Asdiscussed, such fluids F and/or other substances can be subsequentlydelivered to a downstream handpiece assembly from one or more of thesyringes 360. Accordingly, one, two or more different medications,formulations, other fluids and/or other materials can be accurately andconveniently delivered into the anatomy through a single needlepositioned at the distal end of the handpiece assembly. Once a syringe360 has been partially or fully emptied, the inner plunger 364 can onceagain be moved to fill the interior of the syringe 360 with additionalfluids and/or other materials from the corresponding vial or othercontainer positioned on the cassette. For example, once a spent vialpositioned on the cassette is replaced with the a filled vial, a motor,actuator and/or other device within the fluid delivery module can movethe inner plunger 364 relative to the outer barrel 362 of the syringe360 in order to refill the syringe or other reservoir.

According to some embodiments, the syringes 360 (or other reservoirspositioned within a cassette) are filled and emptied with the assistanceof a stepper motor or other mechanical or pneumatic device. For example,such a device can be configured to slidably move the inner plunger 364of each syringe 360 relative to the outer barrel 362. As discussed ingreater detail herein with reference to FIGS. 8 and 11A-12B, fluidsand/or other materials contained within a vial or other container can beselectively loaded into the syringe 360 or discharged from the syringe360 toward a needle at the distal end of a handpiece assembly.Preferably, such a mechanical device, pneumatic device and/or the likecan be configured to precisely move the inner plunger 364 into or out ofthe outer barrel 362 (or otherwise fill and/or empty the syringe 360 orother reservoir) to help ensure that a desired volume of fluids and/orother materials is accurately delivered to the anatomy.

One embodiment of a fluid delivery module 100 configured to accuratelyadjust the position of the syringes' inner plungers 364 relative totheir respective outer barrels 362 is illustrated in FIGS. 13A and 13B.As shown, an interior of the fluid delivery module 100 can comprise oneor more stepper motors 180 or other devices (e.g., pumps, anothermechanical or pneumatic device, etc.) configured to move fluids and/orother materials between vials (or other containers), syringes 360 (orother reservoirs), a handpiece assembly and/or other components of anarticular injection system.

With continued reference to FIGS. 13A and 13B, the fluid delivery module100 can comprise a stepper motor 180 or other device for each syringe orother reservoir positioned within a cassette (not shown). Alternatively,a stepper motor or other device can be configured to control two or moresyringes or other reservoirs. As shown, each stepper motor 180 may beadapted to selectively move a corresponding pusher block 190 along oneor more guide rails 186. In the depicted embodiment, each pusher block190 is configured to move linearly relative to two guide rails 186.However, in other arrangements, a pusher block 190 may be configured tomove in two or more directions, along more or fewer guide rails and/orin a completely different manner, as desired or required.

In the illustrated embodiment, each pusher block 190 includes a verticalportion 192 that is sized, shaped and otherwise adapted to engage theend portion 365 of a syringe's inner plunger 364 (FIG. 12B). Asdiscussed herein with reference to FIGS. 7A and 7B, a cassette 300 caninclude one or more openings 324 adjacent to the syringes 360.Accordingly, the vertical portion 192 of each pusher block 190 can beconfigured to extend through such an opening 324 of the cassette 300 inorder to engage a movable portion of the syringe 360 (e.g., the endportion 365 of the inner plunger 364).

In FIG. 13A, the vertical portion 192 of the pusher block 190 comprisesa slot 194 that is sized, shaped, positioned and otherwise configured tosecurely receive the end portion 365 of the inner plunger 364. Thus, asthe pusher block 190 is moved along the guide rails 186, the position ofthe inner plunger 364 relative to the outer barrel 362 can beselectively modified. As discussed, this permits fluids and/or othermaterials to be loaded into the cassette and/or accurately delivered toa targeted anatomical location through a handpiece assembly. In order toensure that the position of the pusher blocks 190 is being accuratelycontrolled, the fluid delivery module 100 can comprise one or moresensors (e.g., optical sensors), other position detection devices and/orthe like. It will be appreciated that different methods and/or devicesfor controlling the loading of vials or other containers and/or thesubsequent delivery of fluids and/or other substances may bealternatively used.

As discussed, medicaments and/or other fluids or materials to bedelivered to a targeted anatomical location (e.g., a toe, ankle, knee,other joint, organ, etc.) are typically provided to clinicians and otherusers of an articular injection system in standard or non-standard drugvials. The size or capacity (e.g., 5 ml, 10 ml, 50 ml, etc.), shape,material type (e.g., glass, plastic, acrylic, etc.) and/orcharacteristics of such vials can vary. As discussed herein withreference to various embodiments of a cassette (e.g., FIGS. 3A and 4A),it may be desirable to secure such a vial 400A-400B to a loading area370, 370A, 370′ or other portion of the cassette 300 or fluid deliverymodule 100. This can facilitate delivery of the internal contents of thevials to the anatomy using an injection system. Accordingly, asillustrated in FIGS. 14A and 14B, a nest 370, 370A or loading area canbe configured to receive one or more nonspecific containers (e.g., vialsof varying sizes, shapes, capacities, etc.) 400, 400′, 400″, 400″′.

Vial Adapters

According to certain embodiments, a vial adapter is used as an interfacebetween a vial and the nest or other portion of the cassette or fluiddelivery module. As discussed in greater detail herein, such adapterscan make it easier and safer to load the desired medications,formulations and/or other fluids or materials to the injection systemand to selectively deliver them within the anatomy.

In some arrangements, a loading area or nest of a cassette (or anotherportion of a fluid delivery module) is configured to receive anonspecific container. Regardless of their exact size, shape, capacityand/or other characteristics, nonspecific containers can be secured tothe loading areas or nests using the various adapter embodimentsdisclosed herein. Thus, in one embodiment, the two or more vials orother nonspecific containers secured to a fluid delivery module may bedifferent from each other (e.g., in size, shape, capacity and/or thelike).

The ability to mount or otherwise secure nonspecific containers (e.g.,vials of varying sizes, shapes, capacities, etc.) to a loading area of acassette or other portion of the fluid delivery module can providecertain advantages. Such configurations can eliminate the need for twoor more different fluid and/or other material streams to be premixed inpreparation for an injection procedure. For example, where two, three ormore different types of medicaments and/or other substances are neededin a particular injection protocol, a physician, nurse or otherclinician may need to combine such fluids and/or other materials in asingle syringe or other container in advance of the injection procedure.As a result, such a preliminary step can lead to errors, waste,potentially unsafe conditions for the patient or other problems. Forexample, one or more of the medications, formulations and/or othersubstances can be contaminated as they are exposed to the environmentwhile being transferred to a different container. In addition, increasedprobability of human error associated with performing such pre-injectiontransfers can increase the likelihood that the subsequent injectionprocedure will be ineffective and/or harmful for the patient. Forinstance, the type, volume or other amount, dosage, relative proportionand/or other properties of each of the medicaments and/or othermaterials being combined may be incorrect or inaccurate.

Further, it may not be advisable to combine certain medications and/orother substances with each other too far in advance of their injectioninto the anatomy. For instance, one or more of these fluids and/ormaterials may undesirably degrade or otherwise transform (e.g.,chemically, biologically or otherwise) as a result of the premixing.Likewise, certain fluid and/or other material streams may not bephysically compatible with each other (e.g., due to differences indensities, viscosities, affinities to certain substances, etc.).Moreover, having to transfer the contents from one container (e.g., thevial in which a particular medicament was supplied) to another (e.g., aninjection syringe) can lead to waste, as a residual volume of thecontents of the supply vial or other container is wasted. This can beparticularly significant when a medication and/or other material isrelatively expensive. Further, the need of transferring fluids and/orother materials from separate vials or other container into a singlecontainer that will be used to administer a desired formulation during asubsequent injection procedure can be labor and cost intensive.

Accordingly, the various embodiments disclosed herein that permitnonspecific containers (e.g., drug vials) to be secured to a cassette oranother portion of a fluid delivery module can be safer, more costefficient, more effective and reliable, less wasteful, less burdensomeon labor and other resources and/or the like. Thus, the injectionsystems, devices and methods discussed and illustrated herein, andequivalents thereof, can permit two or more different types ofmedications, formulations and/or other fluids or materials to bedelivered to an anatomy without the need for premixing or combining suchsubstances prior to loading the nonspecific containers in which suchsubstances were supplied onto a fluid delivery module.

One embodiment of a vial adapter 450 is illustrated in FIG. 15A. Asshown, the adapter 450 can include a base 454 having a generallycircular shape. In the depicted arrangement, the base 454 of the adapter450 comprises two rectangular openings 456 and two circular openings458. These openings 454, 458 can be sized, shaped and otherwiseconfigured to receive one or more portions of a nest or other componentof the cassette. The adapter 450 can also preferably include a pluralityof arms 470 or other members that extent outwardly from the base 454.According to some arrangements, the base, arms and/or other portions ofthe adapter 450 comprise one or more resilient, rigid, semi-rigid and/orflexible materials, such as, for example, plastic, other polymericmaterials, rubber, metal, other synthetic or natural materials and/orthe like.

As illustrated in FIG. 15A, regardless of its exact shape, size and/orother characteristics, the adapter 450 can be advantageously configuredto be secured to any one of a number of different types and sizes ofvials or other containers. Specifically, vials 400′, 400″, 400″′ orother containers can have a different in size (e.g., diameter), shape,type of closure and/or the like. For example, in the depictedarrangement, the size and shape of the vessel portion 404′, 404″, 404″′of the vials 400′, 400″, 400″′ vary from each other. There may alsoexist variations in the diameter, height and other characteristics ofthe neck portions 406′, 406″, 406″′, closures 410′, 410″, 410″′ andother areas of the vials. Thus, it may be desirable to provide a singlevial adapter design that can be used with a large number of differentvials 400′, 400″, 400″′ or other containers.

FIGS. 15B-15D provide detailed views of the vial adapter 450 illustratedin FIG. 15A. As shown, the arms 470 can be arranged in a generallycircular pattern to define a center opening 471 through which the top ofthe vial (e.g., the closure) can be inserted. The arms 470 extend fromthe base 454 and include a main portion 472 that is generallyperpendicular to the base 454. In some arrangements, the arms 470terminate with a grasping portion 476 located at the ends of therespective main portions 472. In FIGS. 15B-15D, the grasping portions476 have a generally curved shape that face inwardly toward each other.However, in other embodiments, the shape, size and/or othercharacteristics of the arms 470 of the adapter 450 can be modified, asdesired or required.

According to some embodiments, the arms 470 of the adapter 450 areconfigured to be resilient or substantially resilient (e.g., configuredto flex in a radial direction when an outwardly-oriented force isexerted on them). Thus, as the closure 410′, 410″, 410″′ (FIG. 15A) of avial is inserted into the center opening 471 of the adapter 450, thearms 470 may be forced outwardly if the outer diameter of the closure isgreater than the diameter of the center opening 471 defined by theplurality of arms 470. Consequently, the outer diameter of the closure410′, 410″, 410″′ is advantageously permitted to slide within theopening 471 and past the grasping portions 476 of the flexed arms 470.Once the entire height of the closure 410′, 410″, 410″′ has cleared theedges 477 of the grasping portions 476, the arms 470 can resilientlyretract inwardly (e.g., to or near their original non-biased position).In such embodiments, since the closure 410′, 410″, 410″′ of the vial istrapped underneath the plurality of arms 470, the vial can beconfidently secured to the adapter 450.

Accordingly, the adapter 450 can be configured to engage many differenttypes of vials or other containers. In some embodiments, the adapter 450is sized, shaped and otherwise adapted to be secured to and be used withsome, most or all types of vial designs and configurations. For example,FIG. 15E illustrates the adapter 450 of FIGS. 15A-15D secured to threedifferent types of vials 400′, 400″, 400″′. Such adapters 450 can beused to account for the different types of vials or other containers inwhich various medications, formulations, other fluids and/or othermaterials typically injected into the anatomy (e.g., joints) areprovided to clinicians. In some embodiments, the adapters 450 areconfigured to mate with the loading areas or nests 370 of the cassette300 (FIG. 15F). Consequently, the adapters 450 can facilitate the properloading of a vial or other container onto the cassette or other portionof the fluid delivery module.

In some embodiments, once an adapter 450 is secured to a vial, theadapter 450 cannot be removed without irreversibly damaging one or moreportions of the adapter 450 or vial 400. For instance, it may benecessary to break one or more arms 470 of the adapter 450 and/or removethe closure 410 of the vial in order to separate the vial 400 from theadapter 450. According to some arrangements, vials are supplied toclinicians or other end users with the adapters 450 already attached. Inother embodiments, the adapters 450 are supplied without the adapters.Thus, a clinician, nurse, other user or other party within the supplystream may need to secure the adapters 450 to the vials prior to usewith an injection system.

FIG. 15F illustrates one embodiment of an adapter 450 that serves as aninterface between the loading areas or nests 370′ of a cassette 300 andthree different types of vials 400′, 400″, 400″′. Thus, the adapters 450can help secure the various vials that may be necessary for a particularinjection procedure to the cassette 300. In some arrangements, one ormore devices and/or methods are used to help lock or otherwise secure avial/adapter combination to a nest 370′ or loading area. For example, asillustrated in FIGS. 15B-15D, the adapter 450 can comprise one or moreopenings 456, 458 along its base 454. Such openings 456, 458 can beconfigured to receive corresponding features or components of a nest370′.

By way of example, the embodiments of the loading area or nest 370′depicted in FIGS. 5A-5E comprise a pair of generally cylindrical posts374′ and a pair of wings 376′. Accordingly, the circular and rectangularopenings 458, 456 of the adapter disclosed in FIGS. 15B-15D may beadvantageously sized, shaped and otherwise configured to receive theposts 374′ and wings 376′ of the nest 370′. As best shown in FIG. 5B,the posts 374′ can be offset relative to the adjacent wings 376′.Likewise, as illustrated in FIG. 15C, the circular openings 458 can beoffset relative to the adjacent rectangular openings 456. Consequently,the posts 374′ of the nest 370′ and the corresponding circular openings458 of the adapter 450 can help ensure that the adapter 450 is properlyaligned with the nest 370′ when a vial is being mounted to a cassette300 or another portion of a fluid delivery module.

In the embodiment illustrated in FIG. 15F, when the vial/adaptercombination is being secured to the cassette 300, the wings 376′ of thenest 370′ extend through the corresponding rectangular openings 456(FIGS. 15B-15D) of the adapter 450. As shown, at least a portion of thewings 376′ can include one or more teeth 378′ or other surface featuresthat are sized, shaped and otherwise adapted to engage the rectangularopenings 456 in a ratchet-type manner. For example, the teeth 378′ orother surface features of the wings 376′ can be sloped in a manner thatpermits the vial/adapter combination to be advanced only in onedirection (e.g., toward the top surface of the cassette 300). This canensure that the vials 400′, 400″, 400″′ are maintained in a desiredvertical orientation relative to the respective loading areas or nests370′ of the cassette 300. In some embodiments, the ratchet-type lockbetween the teeth 378′ of the wings 376′ and the rectangular openings456 can be released by squeezing the wings 376′ closer to each other.This can permit the teeth 378′ to disengage from the adjacent surfacesof the openings 456, thereby allowing the vial/adapter combination to beselectively moved away from the cassette 300. Consequently, when theinternal contents of a vial 400′, 400″, 400″′ have been emptied, a usercan remove the vial/adapter combination and load another one on therespective nest 370′.

FIG. 15G illustrates an exploded perspective view of a vial 400configured to be positioned within a loading area or nest 370′ of acassette. The adapter that would normally be secured to the neck 406 andclosure 410 of the vial 400 has been omitted from the depictedarrangement for purposes of clarity. As shown, the nest 370′ can includeone or more vertical slots 373′ along its cylindrical portion 372′. Inthe depicted embodiment, the cylindrical portion 372′ comprises a totalof two vertical slots 373′ that are oriented opposite of each other.However, in other configurations, the quantity, shape, size, position,spacing and/or other details of the slots 373′ can vary as desired orrequired.

As illustrated in FIG. 15G, an intermediate member 420 and a spring 426can be positioned within the interior of the cylindrical portion 372′ ofthe loading area or nest 370′. In some embodiments, the intermediatemember 420 includes a pair of protrusions 422 that are sized, shaped,spaced and otherwise configured to fit within the vertical slots 373′ ofthe nest 370′. A spring 426 or other resilient member can be used toensure that the intermediate member 420 is normally urged upwardly,generally toward the top of the vertical slots 373′. FIG. 15Cillustrates a cross-sectional view of one embodiment in which theintermediate member 420 and the spring 426 are positioned within thecylindrical portion 372′ of the nest 370′.

With continued reference to FIGS. 15G and 15C, the intermediate member420 can include a septum 424, membrane or other portion that isconfigured to be selectively pierced by the main needle 332 and/or thevent needle 380. In some arrangements, the septum 424 comprises agenerally circular shape and is located near the center of theintermediate member 420. Preferably, the septum is adapted to bere-sealable or substantially re-sealable once one or more needles 332,380 have been removed from it. Accordingly, the inclusion of such anintermediate member 420 and spring 426 within the loading area or nest370′ can help ensure that the needles 332, 380 are shielded fromcontamination when a vial 400 is not positioned within a nest 370′.

When a vial/adapter combination is loaded onto a loading area or nest370′, the top surface of the vial's closure 410 will initially contactthe intermediate member 420. As the vial/adapter combination is loweredtoward the cassette, the intermediate member 420 can be urged againstthe resilient force created by the spring 426. During this process, theprotruding members 422 of the intermediate member 420 can slide withinthe vertical slots 373′ of the nest 370′. Eventually, according to somearrangements, the main needle 332 and the vent needle 380 will penetrateboth the septum 424 of the intermediate member 420 and the septum 414 ofthe closure 410 in order to access the interior of the vial 400.Likewise, when the vial/adapter combination is removed from the loadingarea or nest 370′, the spring 426 can help return the intermediatemember 420 to its normal position illustrated in FIG. 15C. Consequently,when a nest 370′ does not have a vial 400 loaded therein, the needles332, 380 can be advantageously protected from the outside environment bythe intermediate member 420. As discussed, such an intermediate member,cover or other protective member can be used with any nest embodimentdisclosed herein or equivalent thereof.

FIGS. 15A-15F illustrate only one embodiment of releasably securing avial adapter 450 to a loading area or nest 370′. Alternativearrangements for doing so are discussed herein with reference to FIGS.16A-18D.

FIGS. 16A-16D illustrate an alternative configuration of securing a vialadapter 450A to a loading area or nest 370′. Similar to the arrangementof FIGS. 15A-15F, the depicted vial adapter 450A comprises a base 454Aand a plurality of arms 470A extending perpendicularly therefrom. Inaddition, the adapter 450A can include one or more openings (e.g.,circular openings, rectangular openings, etc.) that are sized, shapedand otherwise configured to receive posts 374′, wings 376′ and/or otherfeatures of the nest 370′. As shown, the vial adapter 450A can includetwo push button assemblies 480 that, when pushed inwardly, areconfigured to release the vial adapter 450A from the nest 370′. Thus, auser can easily remove a vial from the loading area or nest when theinternal contents of such a vial have been transferred to the cassette.

With continued reference to FIGS. 16A-16D, the push button assembly 480can include a button 488 that is connected to one or more struts 486. Inone embodiment, as the button 488 is depressed, the struts 486 exert aforce on the adjacent wing 376′ of the nest 370′. Accordingly, the wing376′ is urged inwardly (e.g., toward the center of the nest 370′) sothat the teeth 378′ of the wings 376′ move out of engaging contact withan adjacent lip 482 of the adapter 450A.

Another embodiment of a vial adapter 450B is illustrated in FIGS.17A-17C. As shown, the adapter 450B can comprise one or more holders 494along its base 454B. In some arrangements, such holders 494 are sized,shaped and otherwise configured to securely receive posts 374′ and/orother features of a nest 370′. In some arrangements, the holders 494 areadapted to normally prevent movement between the adapter 450B and thenest 370′ in one or both directions. For example, the posts 374′ of thenest 370′ can be permitted to slide relative to the holders 494 only ina direction that moves the adapter 450B closer to the nest 370′. Theadapter 450B can include one or more release levers 492 that whenproperly actuated (e.g., upwardly) can allow the posts 372′ to sliderelative to the holders 494 in either vertical direction so that thevial/adapter combination can be removed from the nest 370′.

Various views of yet another embodiment of a vial adapter 450C areprovided in FIGS. 18A-18D. As shown, the adapter 450C can include alower portion 496 that extends below a base 454C. In some arrangements,such a lower portion 496 can include one or more lips 498 along itsinterior surface that are sized, shaped and otherwise configured to matewith a corresponding engagement feature 377″ of a nest wing 376″. Aswith other arrangements discussed and illustrated herein, the base 454Cof the adapter 450C can include one or more openings (e.g., rectangularopenings 456C, circular openings 458C, etc.) that are configured toreceive wings 376″, posts or other features or portions of the nest 370″or loading area. Once a vial (not shown) is secured to the adapter 450C,the rectangular openings 456C can be aligned with the wings 376″ of thenest 370″ and urged toward the cassette. When the adapter is movedsufficiently far relative to the nest 370″, the lips 498 along theinterior of the adapter 450C can come into locking contact with thecorresponding engagement features 377″ of the wing 376″. Thus, thevertical position of the adapter 450C relative to the nest 370″ orloading area can be advantageously maintained. Once the user desires toremove the vial/adapter combination from the nest 370″ (e.g., in orderto discard a spent vial, replace a spent vial with a new vial, etc.), heor she can depress the sides of the adapter's lower portion 497 (e.g.,along the textured region 497) so that the overall shape of the adapter370″ is modified. If the sides 497 of the adapter 450C are squeezed withsufficient force, the lips 498 and the corresponding features 377″ canbe disengaged, thereby allowing the adapter to be removed from the nest370″. It will be appreciated that one or more other methods or devicesfor releasably locking an adapter to a loading area, nest or otherportion of a cassette or fluid delivery module can be used, either inlieu of or in addition to the specific embodiments discussed andillustrated herein.

In some embodiments, as illustrated in FIGS. 19A-19C, vial adapters 450Dcomprise one or more identification flags 460 or other members thatinclude a machine readable code or pattern 462. In the illustratedarrangement, the flag 460 extends upwardly from the base 454D of theadapter 450D in a direction generally opposite of the vial 400 to whichthe vial 400 is secured. The identification code or pattern 462 on theflag 460 can include a barcode, an identifiable graphical or colorpattern, a numerical code, an RFID or other radio frequency code and/orthe like. For example, in some embodiments, the identification flag 460or other member comprises the National Drug Code (NDC) number of theparticular medication or other formulation contained within the vial 400to which the adapter 450D is secured.

With continued reference to FIG. 19C, the loading area or nest 370′ caninclude an opening 375′ through which the identification flag 460 of theadapter 450D may pass as the adapter 450D is secured to the nest 370′ orother portion of the cassette or fluid delivery module. In someembodiments, the cassette or other portion of the fluid delivery moduleincludes a reader (e.g., barcode scanner, RFID reader, etc.) that isconfigured to automatically detect the identifiable pattern 462 of theflag 460 when the adapter is secured to the nest 370′. Accordingly,assuming the correct adapter 450D is secured to a vial 400, the fluiddelivery module can be advantageously configured to automatically detectthe various medications, formulations, other agents and/or other fluidsor materials that are being loaded into the cassettes. This can helpimprove the safety of the articular injection system as the likelihoodof potentially dangerous errors can be eliminated or reduced.

Vials containing medications and/or other materials used during aninjection procedure can be supplied with such vial adapters 450D alreadyattached to them. In other arrangements, a clinician, another userand/or someone higher in the supply chain to the end users may beresponsible for securing the correct vial adapters 450D to the vials400.

In some embodiments, the internal contents of a vial or other containerto be loaded onto a fluid delivery module can be detected, eithermanually or automatically, using one or more other identificationdevices. For example, the fluid delivery module and/or another portionof the injection system can include a barcode reader, RF reader or othertype of identification device (not shown). In one arrangement, a scanneris positioned along an exterior surface of the fluid delivery modulehousing. Such an identification device can be adapted to read a barcode,RFID patch and/or any other label, signal or the like of a vial (orother container of anesthetics or other pain-relieving medication,steroid, saline, pharmaceutical compositions, hyaluronic acid, othermedications or drugs, cells, liquid and non-liquid fluids and flowablematerials, nanoparticles, cement, microbeads, etc.).

An vial identification device can permit a user to quickly, easily andsecurely verify the type, dosage, strength and other details of themedication, fluid and/or other material that will be delivered to thetargeted anatomical location by the injection system. Thus, in someembodiments, once a particular treatment or delivery sequence isselected, a clinician or other user can confirm that the correctmedications, fluids and/or other materials are loaded into the fluiddelivery module using such an identification device (e.g., scanner, RFreader, etc.). For example, once a particular joint treatment isselected, the required vials or other containers of anesthetics,steroids or other therapeutics (such as hyaluronic acid and/or the like)can be confirmed using a scanner or other identification device beforeloading the corresponding vials into the cassette or other portion ofthe fluid delivery module.

As discussed, it may be desirable or necessary to maintain the internalcontents of a vial or other container mixed while such vial or othercontainer is positioned on the cassette. For example, certain types ofsteroids or other formulations that include a relatively high solidsconcentration may need to be mixed to ensure that a consistent andhomogeneous dose is provided to the patient during an injectionprocedure. Thus, one or more devices or methods of agitating theinternal contents of a vial or other container can be advantageouslyprovided. One embodiment of such an agitation system is discussed hereinwith reference to the nest 370A or loading area illustrated in FIGS.3K-3S.

Another arrangement configured to mix the contents of a vial or othercontainer secured to a fluid delivery module is illustrated in FIGS.20A-20C. Similar to other standard or non-standard vials or othercontainers discussed and illustrated herein, the depicted mixable vial430 comprises a neck portion 434 and a closure 436 to which an adapter(not shown) may be selectively secured. As shown, a stopper 440 can bepositioned at the opposite end of the vessel 432 to define a sealedinterior space 433 into which steroids and/or other fluids or materialsmay be placed. In order to ensure that the interior space 433 isproperly sealed, one or more O-rings 435 or other sealing members can beused between the vessel 432 and the stopper 440.

With continued reference to FIGS. 20A-20C, the vial 430 can include oneor more agitators 444 configured to continuously or intermittently stirthe interior space 433. In the illustrated embodiment, the vialcomprises a single agitator 444 that includes a corkscrew shape andextends throughout most or all of the length of the vessel 432. However,in other arrangements, the quantity, shape, size and other details ofthe agitator 444 can vary, as desired or required. The agitator 444 canbe mechanically coupled to a gear 448 using a pin 449 or otherconnection device or method. In some embodiments, the gear 448 iscoupled to a motor (not shown) that can cause the agitator 444 to rotateor otherwise move in order to mix the internal contents (e.g., steroids)of the vial 430.

When injecting fluids and/or other materials into the anatomy thatrequire continuous or intermittent mixing, it may be desirable totransfer such fluids and/or other materials from the vial 430 to thecassette 300 on as needed basis. For example, the fluids or materialscan be maintained in an agitated state within a mixable vial 430 orwithin a rotatable nest 370A or loading area (FIGS. 3K-3S) untilimmediately before the injection procedure is commenced. Otherwise, ifsuch fluids and/or other materials are permitted to becomenon-homogenous, the effectiveness of the injection procedure may benegatively affected. It will be appreciated that other devices and/ormethods of agitating the contents of a vial 430 can be used, either inaddition to or in lieu of the specific embodiments disclosed herein.Further, it may be necessary to provide temperature control to one ormore of the vials, the cassette and/or another portion of the articularinjection system. For example, temperature control may be needed toprevent degradation or decomposition of a particular medication,composition or other material being delivered during an injectionprocedure. Accordingly, the fluid delivery module, the handpieceassembly and/or another portion of the injection system can beselectively temperature controlled. Such climate control can beaccomplished using heating, refrigeration and/or other techniques knownto those of skill in the art. For example, one or more components of theinjection system can include refrigeration or heating units,thermostats, necessary controls and/or the like.

C. Handpiece Assembly General

As discussed herein with reference to FIGS. 1 and 2, an articularinjection system 10 can include a handpiece assembly 200 that serves asan interface between the fluid delivery module 100 and the targetedanatomical location T to which one or more fluids and/or other materialsare to be delivered. One embodiment of such a handpiece assembly 200 isillustrated FIGS. 21A and 21B. As shown, the handpiece assembly 200 caninclude several different portions that are selectively removable fromand attachable to each other. This can help reduce or minimize thenumber of items that need to be discarded and/or cleaned (e.g.,sterilized) over time and/or between procedures. As a result, materialand operational costs, as well as the amount of waste that is generatedover time, can be advantageously reduced. In addition, the efficiencywith which the system is operated and maintained can be improved.

As discussed in greater detail herein, the handpiece assembly permits auser to selectively deliver one, two or more different medicaments,other fluids and/or other materials into a patient's anatomy through asingle needle positioned at the distal end of the device. In someembodiments, a clinician uses buttons and/or other controllerspositioned on the handpiece assembly to control the delivery of thevarious fluids and/or other materials through the assembly. A user canmanipulate such buttons or other controllers to modify one or moreaspects of the injection procedure (e.g., which fluids are beingdelivered, sequence of delivery, flowrate, etc.) while continuing tograsp and manipulate the handpiece assembly. Accordingly, in someembodiments, a user executes a desired procedure without taking his orher hands off the handpiece assembly.

Moreover, at least some of the various embodiments of the handpieceassembly discussed herein permit two or more different fluids and/orother materials to be transferred to or near a needle without priormixing or cross-contamination of the various streams. Thus, in someembodiments, the different fluids and/or other substances are mixed justprior to entering the needle. As discussed in greater detail herein, thevarious fluid or other material streams can be mixed at a distal end ofthe clip (e.g., a common or collection area), at or near the interfacebetween the clip and the disposable tip and/or at any other location. Incertain situations, the effectiveness of an injection may be enhanced ifthe contact time between the various fluids and/or other substancesbeing delivered into a patient is reduced or minimized (e.g., forvarious chemical, biological and/or other reasons). Relatedly, thehandpiece assembly can be adapted to prevent backflow of fluids and/orother materials being transferred therethrough. This can help reduce thelikelihood of cross-contamination or inadvertent mixing of the variousmedicaments and other substances. For example, as discussed, thehandpiece can include various valves (e.g., duckbill valves, combinationduckbill/umbrella valves, other check valves, etc.) and/or otherbackflow prevention devices.

In some embodiments, the handpiece assembly includes buttons and/orother controllers that are used to operate another device, such as, forexample, an ultrasound device or another imaging system. Such buttons orother controllers can be included either in lieu of or in addition tothe buttons and controllers on the handpiece for the operation of theinjection system itself. Thus, a clinician or other user canadvantageously control the operation of an ultrasound or other imagingdevice and/or any other system using only the handpiece assembly. As aresult, the clinician can control and complete an injection procedurewhile continuing to hold the handpiece assembly (e.g., without the useof any other device or system). Accordingly, this can help improve thesafety and accuracy of a procedure as the user is permitted to operatevarious systems during an injection while continuing to hold andmanipulate the handpiece assembly.

In addition, as discussed in greater detail herein, configuringdifferent devices and systems to interface with one another during aninjection procedure can provide additional benefits. For example,information about the delivery of fluids and/or other substances (e.g.,the volume of each medicament delivered, the volume of each medicamentremaining, the flowrate of medicament through the handpiece, etc.) canbe incorporated into the same visual display with the graphics of anultrasound or other imaging technology. As discussed in greater detailherein, this can further facilitate the execution of an injectionprocedure. In addition, such a configuration can improve record-keeping,billing and other functions that are related to the administration of amedical procedure.

For example, in one embodiment, the handpiece assembly 200 comprises acore 210, a clip assembly 240 and a tip 280 having a needle 290 alongits distal end. A delivery line 250 comprising one or more differentconduits 251 (FIG. 7B) can be used to place the handpiece assembly 200in fluid communication with the cassette 300 and/or another portion ofthe fluid delivery module 100. In one embodiment, the tip 280 isreplaced after each injection (e.g., immediately following removal ofthe needle 290 from the anatomy). Further, the clip assembly 240 can bereplaced when the type and/or dosage of the medications, formulationsand/or other materials being delivered through the handpiece assembly200 are modified. As discussed, in some embodiments, the clip assembly240, the delivery line 250 and the cassette 300 can be supplied andreplaced as a single system or kit as desired or required.

The handpiece assembly 200 can be adapted to allow a clinician or otheruser to easily grasp and manipulate it during an injection procedure. Assuch, the diameter, length, other dimensions and/or othercharacteristics of the handpiece assembly 200 can be advantageouslyselected to achieve the desired functional and/or aesthetic goals.Further, the handpiece assembly 200 can include a shape, other features(e.g., finger grooves, tactile members or outer surface, etc.) and/orthe like to further enhance its ergonomic and/or other properties.According to some arrangements, the approximate diameter and totallength (e.g., not including the needle 290) of the handpiece assembly200 are approximately 5 to 6 inches and approximately 0.5 to 0.7 inches,respectively. In addition, the various components of the handpieceassembly 200, including the core 210, clip 240, tip 280 and the like,can be manufactured using one or more materials that are durable andotherwise suitable to withstand the forces and wear and tear to whichthe handpiece assembly 200 may be exposed. For example, in severalembodiments, the handpiece assembly 200 comprises plastics, otherpolymeric materials, metals, alloys and/or any other synthetic ornatural materials.

In some embodiments, the clip assembly 240 is replaced according to aparticular schedule or protocol. For instance, the clip assembly 240(and, in certain arrangements, the delivery line and the cassettetogether with the clip assembly) can be replaced following apredetermined number of injection procedures, following a predeterminedvolumetric amount of fluids and other materials passing through the clipassembly 240, based on a predetermined time frequency (e.g., once a day,once every four hours, etc.) and/or according to some other set ofrules, as desired or required by the particular application or use. Insome arrangements, the core 210 is advantageously configured to notcontact any fluids and/or other materials being conveyed through thehandpiece assembly 200. As a result, the same core 210 can be usedrepeatedly without the need to replace or clean it. However, it will beappreciated that even such a core 210 may need to undergo frequentcleaning (e.g., sterilization), calibration and/or other maintenanceprocedures. Each component of such a handpiece assembly 200 is discussedin greater detail herein.

Handpiece Core

FIGS. 22A and 22B illustrate different views of the core 210 included inthe handpiece assembly 200 of FIGS. 21A and 21B. As shown, the core 210can comprise a control portion 220 having one or more buttons 222, 224,226, controllers and/or other adjusting devices (e.g., knobs, dials,switches, etc.). In addition, the control portion 220 can include one ormore indicator lights 228 and/or any other feature that providesinformation to the user regarding the operation of the assembly 200and/or the injection system.

The buttons 222, 224, 226 and/or other control features of the core 210can help regulate the delivery of various fluids and/or other materialsthrough the handpiece assembly 200. For example, such buttons 222, 224,226 can be used to activate or deactivate (e.g., ON/OFF) the supply(and/or withdrawal) of fluid or other substances to or from anintra-articular space or other anatomical location. In certainarrangements, the buttons or other controllers are manipulated toregulate the rate of delivery (e.g., flowrate) of one or more medicantsand/or other materials being transferred through the handpiece assembly.As discussed, in other embodiments where the fluid delivery module is indata communication with one or more other components or devices (e.g.,ultrasound devices, radio frequency spectroscopy devices, other imagingdevices or systems, etc.), buttons or other controllers can be used toalso regulate the operation of such systems. For example, as discussedin greater detail herein, the buttons or other controllers of ahandpiece assembly can be used to capture an ultrasound image or videowhile a target anatomical space (e.g., a joint, organ, etc.) is beinglocated and/or while one or more fluids or other materials are beinginjected into a target anatomical location. Alternatively, the buttonsor other controllers can be used to vary one or more other aspects of animaging system, such as, for example, zoom, resolution, contrast,brightness and/or the like. In some embodiments, a handpiece assemblyincludes additional, fewer and/or different buttons, knobs, leversand/or other control devices that permit a user to control one or moreaspects of the system.

With continued reference to FIG. 22A, each of the buttons 222, 224, 226along the outside of the core 210 can be configured to correspond to oneof the medications and/or other materials which are loaded onto thefluid delivery module 100 and which can be selectively delivered from tothe handpiece assembly 200. For instance, each such medication, otherfluid or the like can be associated with a particular color, shape,pattern, design, scheme, texture, other identifying feature and/or thelike. Thus, in some embodiments, the color, shape or pattern of thebuttons 222, 224, 226 is configured to match a correspondingcharacteristic of the medications and/or other materials that are loadedonto the fluid delivery module (e.g., positioned on the nests or loadingareas of the cassette). By way of example, one of the buttons 222 on thecore can be yellow. In addition, the user may have selected yellow toalso correspond to a particular type of therapeutic agent (e.g.,steroid) which is loaded onto the cassette and which may be selectivelydelivered from the fluid delivery module to the handpiece assembly 200(see FIGS. 48A-48D and 49A-49D for additional information regardingmatching a particular medication and/or other material to a button ofthe handpiece assembly). In another embodiment, the buttons are texturedin a manner that permits a clinician or other user who handles thehandpiece assembly to identify the various buttons without having tolook at them. For example, the buttons can include a raised or recessedpattern (e.g., a “plus” or “minus” sign, dots, a rectangle, circle,other geometric design, other discernable pattern and/or the like).Thus, by pressing the appropriate button 222, the user can commence,terminate, speed up, slow down and/or otherwise adjust the delivery of atherapeutic agent and/or other fluid or substance to the patient.

According to certain embodiments, a handpiece assembly 200 comprises oneor more two-mode or other multi-mode buttons and/or other controllers.Pressing or otherwise manipulating such a button can alternatelycommence or terminate the delivery of one or more fluids and/or othermaterials through the assembly. Alternatively, the handpiece assembly200 can include one or more other types of buttons or controllers. Insome arrangements, the buttons are configured to permit the user toselect between two, three or more different settings. In otherembodiments, a button is of the multi-depth type (e.g., dual-depth,tri-depth, etc.), enabling a user to selectively press the button to twoor more distinct depths or other levels. Each distinct depth or levelcan correspond to a particular setting (e.g., flowrate, selection ofwhich fluids or other materials to deliver, etc.). For example, pressingthe button to the first level can cause the desired fluid and/or othermaterial to be conveyed at the maximum or minimum rate. Further,continuing to press the button to subsequent lower levels can cause therate of delivery to increase, decrease or terminate. In otherembodiments, the handpiece assembly comprises multi-depth buttons thatdo not include distinct depths, such as, for example, a rheostat. Thus,a particular setting (e.g., flowrate) can be varied based on the depthto which a button is depressed.

In other arrangements, the core 210 of the handpiece assembly comprisesone or more buttons that have only two positions, but which areconfigured to permit a user to select between three or more differentsettings. For example, an injection system can be adapted tosequentially move between different flowrate settings (e.g.,high-medium-low-off, vice versa, etc.) every time such a button ispressed.

As discussed, a core 210 or other portion of a handpiece assembly cancomprise other types of controllers, either in lieu of or in addition tothe buttons. For example, the handpiece assembly 200 can include aroller ball, a roller wheel, a dial, a knob, a modulating switch orother device and/or the like. Regardless of their exact configurationand design, such control devices can enable a clinician or other user toregulate the delivery of fluids and/or other materials from the fluiddelivery module to a patient. As discussed, the various fluids and/orother materials can be delivered through the handpiece assemblysimultaneously or sequentially, as desired or required. For example, thebuttons and/or other controllers can be used to select which fluids orother materials, or combinations thereof, are to be directed through thehandpiece assembly. In other embodiments, the controllers are configuredto control the rate of delivery (e.g., flowrate) of such fluids and/orother substances to a patient. In still other arrangements, the buttonscontrol one or more other aspects of the injection procedure (e.g., thesequence of delivery, an ultrasound or other imaging device that is indata communication with the injection system, etc.).

In other arrangements, the buttons 222, 224, 226 on the handpieceassembly 200 are adapted to guide the user through one or moreuser-interface screens on the display or graphic user interface (GUI)130 (FIG. 2A) on the fluid delivery module 100. Thus, the buttons 222,224, 226 can be used to make selections through one or more menus or thelike.

According to some embodiments, the handpiece assembly 200 is connectedto the fluid delivery module 100 of the injection system 10 using one ormore hardwired connections. However, the handpiece assembly 200 can beconfigured to communicate with the fluid delivery module 100 and/or anyother component of the injection system using a wireless connection,such as, for example, radio frequency (RF), Wi-Fi, Bluetooth and/orlike, either in addition to or in lieu of a hardwired connection. Asdiscussed herein with reference to FIG. 2A, the handpiece assembly 200can comprise a battery that is configured to be recharged when thehandpiece assembly is positioned within a corresponding docking station116 of the fluid delivery module 100. Such a battery (not shown) can bepositioned within an interior portion of the core 210. The dockingstation 116 can be adapted to recharge the battery using electromagneticinduction, simple charging (e.g., using a DC or AC connection), pulsecharging and/or any other charging method or device. Thus, in somearrangements, the battery within the core is permitted to recharge whenthe handpiece assembly is positioned within a docking station 116 of thefluid delivery module. Alternatively, the handpiece assembly 200 maydraw its power from one or more other sources, such as, for example, aDC or AC hardwired connection and/or the like.

As discussed, an interior portion of the core 210 can include a battery,circuitry, indicator light 228 (e.g., LED) and/or any other component orfeature. As illustrated in FIGS. 22A and 22B, the core 210 can includeone or more indicator lights 228 that provide information to theclinician or other user of the assembly prior to, during and/orfollowing an injection procedure. For example, the light 228 can beconfigured to light up when the battery of the assembly is above orbelow a particular threshold level (e.g., adequately charged, in need ofcharging, etc.). Alternatively, the brightness, color and/or othercharacteristics of the indicator light 228 can be configured to changein response to certain conditions. For instance, the properties of thelight 228 can vary based on the strength of the battery, on the signalstrength of the wireless connection (e.g., radio frequency, RF,Bluetooth, etc.) between the handpiece assembly and the fluid deliverymodule or other component of the system and/or the like.

In other embodiments, an indicator light 228 is activated (e.g., lightsup, begins to flash, changes color, etc.) as a warning to the user. Forexample, the triggering event for such an activation can include a lowbattery level, the presence of air or other gas within a fluid deliveryconduit, excessive back-pressure encountered during the delivery of afluid or other material within the anatomy, low fluid level within areservoir of the fluid delivery module, some other breach and/or thelike. According to certain embodiments, the core 210 or other portionsof the handpiece assembly 200 includes a small display (e.g., LCD) thatis configured to provide information to the user in the form of text,graphics and/or the like, either in addition to or in lieu of one ormore indicator lights 228.

Consequently, the inclusion of the various electronic and/or othercomponents and features within a single core 210 or other portion of thehandpiece assembly 200 provides a number of benefits. As discussed, suchconfigurations can permit a clinician or other user to control some orall aspects of an injection procedure without having to take his or herhands off the handpiece assembly 200. In addition, a single handpieceassembly 200 can be adapted to control one or more other devices orsystems which are used during the execution of injection procedures. Forexample, the buttons or other controllers of the handpiece assembly canbe used to advantageously regulate an ultrasound device or other imagingsystem. Although the inclusion of electrical and control componentswithin the relatively limited space of a core 210 is challenging, theconvenience and other benefits associated with using a single handpieceto control some, most or all aspects of an injection procedure can bebeneficial.

As described in greater detail herein, a touchscreen display 130 orother graphic user interface which is either attached to the fluiddelivery module 100 (FIG. 2A) or operatively connected to it can be usedto regulate, at least in part, the function of the handpiece assembly200 and/or other components of the articular injection system 10. Inother embodiments, a separate handheld device, instrument and/or otherdevice or system can be used to control the handpiece assembly 200and/or other components of the injection system. For example, such acontrol device or other instrument can include separate power, controland/or instrumentation wires that are molded within or otherwisepositioned relative to the separate device. In some embodiments, theseparate control device is configured to attach to (e.g., snap orotherwise mount to) or otherwise secure to the handpiece assembly 200using one or more types of connection devices and/or methods.

Moreover, other devices and methods of controlling one or more aspectsor components of the injection system can be used, either in addition toor in lieu of the devices and methods specifically disclosed herein. Insome embodiments, the injection system includes a foot pedal or otheruser-actuated lever or control. Alternatively, the injection system cancomprise control features that are configured to respond to aclinician's or other user's voice commands or prompts, such as, forexample, “START,” “STOP,” “INJECT/DELIVER,” “ASPIRATE,” “INCREASEFLOWRATE,” “DECREASE FLOWRATE,” “CHANGE MODE/SEQUENCE” and/or the like.It will be appreciated that an articular injection system can includeany combination of controls or other features described herein, asdesired by the user or required by a particular application.

In some embodiments, the shape of the core housing 214 and othergraspable portions of the handpiece assembly 200 are configured to beergonomically correct or are otherwise designed to facilitate thehandling and manipulation of the handpiece assembly 200. Further, asdiscussed in greater detail herein, the core 210 can be configured toquickly and easily attach to and detach from one or more othersubcomponents of the handpiece assembly 200, such as, for example, theclip assembly 240 and the tip 280.

Clip Assembly

FIGS. 23A-23D illustrate various views of one embodiment of a clipassembly 240 configured to be used in a handpiece assembly 200. Asshown, the clip assembly 240 can include a ring 242 at or near itsdistal end. In some arrangements, the distal end of the clip assembly240 comprises a recessed surface 243 to which a tip 280 can be removablysecured (FIGS. 21A and 21B). Further, a central portion of the recessedsurface 243 can include an outlet opening 248 into which an inletportion of the tip 280 may be positioned. In addition, the interiorand/or exterior of the ring 242 can comprise one or more tabs 246 and/orrecesses 244 to help secure the clip assembly 240 to the tip 280, thecore 210 and/or any other portion of the handpiece assembly 200.Additional details regarding various tip embodiments are discussed ingreater detail herein with reference to FIGS. 28A-34.

With continued reference to FIGS. 23A-23D, the clip assembly 240 caninclude a main body 256, which in some embodiments is configured to atleast partially define an exterior surface of the handpiece assembly200. At the proximal end of the main body 256, the clip 240 can includeone or more elongate members 258 that are sized, shaped and otherwiseadapted to mate with corresponding portions of the core 210 (FIGS. 22Aand 22B). For example, the elongate members 258 can slide withincorresponding slots 215 (FIG. 22A) of the core 210. In the illustratedarrangement, at least one of the elongate members 258 comprises alocking tab 259 that is adapted to snap into a matching hole 216 (FIG.22A) along the outer surface of the core 210. Thus, if the elongatemembers 258 are inserted sufficiently far into the corresponding slots215 of the core 210, the locking tab 259 of the clip 240 willresiliently engage the matching hole 216 of the core 210. Consequently,the clip 240 can be advantageously locked relative to the core 210. Inorder to separate the clip 240 from the core 210, the locking tab 259can be pressed inwardly so that the tab 259 disengages from the matchinghole 216.

As illustrated in FIGS. 23A-23C, the clip 240 can include a channel 260or other portion that is configured to receive the delivery line 250. Asdiscussed herein with reference to other components, the delivery line250 can include one, two or more of the individual conduits 251A-251Cthat are in fluid communication with the outlets of the various cassettemanifolds (FIG. 7B). Thus, in some arrangements, the channel 260 of theclip 240 is preferably sized and shaped to accommodate all theindividual conduits 251A-251C of the delivery line 250.

One embodiment of the manner in which the individual conduits 251A-251Cof the delivery line 250 are attached to the clip 240 is illustrated inFIGS. 24A-24C. As shown, the conduits 251A-251C can be routed to a maincoupling 262. In the depicted arrangement, the main coupling 262comprises a generally triangular shape and is adapted to fit within acorresponding recessed area 257 of the main body 256. As bestillustrated in FIGS. 24A and 24C, a duckbill valve 264 (or other type ofbackflow prevention valve or device) can be positioned immediatelydownstream of the main coupling 262. Thus, fluids and/or other materialspassing through the passages of the main coupling 262 are not permittedto reverse direction through the main coupling 262. This helps ensurethat there is no cross contamination of the individual conduits251A-251C upstream of the main coupling 262.

Another embodiment of the connection of individual conduits 251A-251C inthe clip 240′ is illustrated in FIGS. 25A-26C. As with the clip 240 ofFIGS. 24A-24C, the depicted arrangement includes a main body 256 thatcan be selectively attached to and/or removed from the core 210.However, as discussed in greater detail below, there are some variationsin the manner in which the conduits 251A-251C are connected to thedistal end of the clip 240′. As best illustrated in the views of FIGS.26A-26C, the conduits 251A-251C can separate from each other a shortdistance upstream of a multi-piece coupling 270. The coupling 270 caninclude an inner portion 274 fitted within an outer portion 272 locatedimmediately downstream of the inner portion 274. According to someembodiments, a duckbill valve 276 or other backflow prevention valve ordevice can be positioned in the fluid path of each conduit 251A-251C,generally between the outer and inner portions 272, 274. Thus, asdiscussed above with reference to FIGS. 24A-24C, the valves 276 can helpprevent cross-contamination of the individual conduits 251A-251C whenfluids and/or other materials are moving through the clip 240′. In theillustrated embodiments, once they have passed through the duckbillvalves 276, such fluids and/or other materials enter a common chamber277 or collection chamber 277 located at the distal end of the outerportion 272. Accordingly, fluids and/or other materials can exit theoutlet opening 248 (FIGS. 23A and 23D), toward a tip 280 attached at thedistal end of the ring 242.

According to some configurations, the inner portion 274 comprises one ormore prongs 275 that are adapted to secure to corresponding areas of themain body 256. Thus, the inner portion 274 and other components of thecoupling 270 can be conveniently attached to the rest of the clip 240.It will be appreciated that one or more other devices or methods can beused to secure the coupling 270 to the clip 240. Further, as shown inFIGS. 25A and 25B, a closure 266 can be used to completely or partiallycover the interior of the channel 260 through which the delivery line250 is routed.

FIGS. 27A-27E illustrate cross-sectional views of various embodiments ofa delivery line 250A-250E configured for use with an articular injectionsystem. As shown, each delivery line 250A-250E can include two or moredifferent conduits 251 or lumens. Accordingly, the depicted arrangementscan advantageously provide a simple design for conveying two or moredifferent types of fluids and/or other materials through a singlemember. For example, the handpiece assembly 200 in fluid communicationwith the fluid delivery module using only a single multi-lumen tubularmember. In addition, the internal configuration and overall design ofthe clip 240 and/or other portions of the handpiece assembly 200 can beimproved by using such a multi-lumen delivery line 250A-250E, especiallywhere available space within the clip or other portion of the handpieceassembly is limited.

Multi-lumen delivery lines 250A-250E, such as those illustrated in FIGS.27A-27E, can be manufactured using one or more methods (e.g., extrusion,injection molding, etc.) and/or one or more suitable materials (e.g.,rubber, polymeric materials and/or the like). In some embodiments, thedelivery lines are at least partially transparent or translucent so thatan optical sensor can detect the presence of undesirable air or othergas bubbles passing therethrough (see FIGS. 7C and 7D). The materialsused in the manufacture of the delivery lines 250A-250E and otherportions of the articular injection system that may come into contactwith medications, formulations and/or any other materials being injectedinto the anatomy preferably satisfy all regulatory standards andrequirements (e.g., medical-grade quality, FDA regulations, etc.).According to some embodiments, the inner diameter of each lumen of thedelivery line is approximately 0.01-0.04 inches (e.g., 0.030 inches).However, the inner diameter can be greater than 0.04 or smaller than0.01, as desired or required.

The structural integrity, diameter, other dimensions, materials ofconstruction, durability, flexibility, pH resistance,chemical/biological resistance, temperature resistance and/or othercharacteristics of the delivery line or other conduits used in theinjection system can be advantageously selected for the particularapplication. For example, the delivery line or other conduit can bemanufactured from medical-grade silicone, polymers, glass, stainlesssteel, copper and/or the like.

Further, the delivery line or other conduit can be configured so itadequately resists the fluids and/or other materials which it maycontact. Further, such delivery lines or conduits can be advantageouslyadapted to withstand the pressures (e.g., positive, negative/vacuum,etc.) to which they may be exposed. Also, in some embodiments, the linesor conduits are configured to withstand a minimum of 2 pounds of jointtensile strength. However, in other embodiments, the structuralcharacteristics of the delivery lines, conduits and/or other componentsof the system can be different. As discussed, some or all of theconduits used in the injection system can be constructed or otherwiseassembled as a single unit. For hygienic, regulatory and/or otherpurposes, the delivery lines and other conduits can be sterile anddisposable.

Tip

As discussed, in some embodiments, the handpiece assembly 200 preferablyincludes a disposable tip that can be easily and quickly discarded andreplaced between injection procedures. One embodiment of a tip 280Aconfigured to be positioned at the distal end of the handpiece assembly200 is illustrated in FIGS. 28A-28E. The tip 280A can include a tipinlet 282A and a tip outlet 284A. As illustrated in FIGS. 28A and 28C,the distal end of the tip 280A can include an annular opening 285Aaround the tip outlet 284A. In some arrangements, this annular opening285A includes interior threads that are adapted to engage correspondinga thread pattern (e.g., standard or non-standard) of a needle hub 294(FIGS. 21A and 21B). For example, the needle hub 294 can be attached tothe annular opening 285A using a standard luer lock connection. Thus, aneedle 290 can be easily secured to and removed from the distal end ofthe tip 280. The tip outlet 284A can be sized, shaped and otherwiseconfigured to fit within the cavity of a needle hub 294.

The type, size (e.g., gauge), length and/or other details of the needle290 can be selected according to a particular application. For example,in some embodiments, the needle has a gauge of approximately 18G-30G anda length of approximately 0.5 to 5.0 inches (e.g., 1.0 to 1.5 inches).However, that the gauge, length and/or other details of the needle canbe greater or smaller than the range indicated herein, as desired orrequired by a particular application.

With continued reference to FIGS. 28A-28E, the tip 280A can include anengagement feature 283A (e.g., locking ring) along one or more of itsproximal surfaces. Such engagement features 283A can be used to enhancethe connection between the tip 280A and the clip ring 242 (FIGS.23A-24C). In some embodiments, an engagement feature 283A of the tip280A is adapted to rotatably connect to a corresponding feature of thering 242 or other portion of the clip 240. It will be appreciated thatany other attachment device or method can be used to removably mate thetip 280A with the distal end of the clip 240.

In some arrangements, the tip inlet 282A extends outwardly (e.g., alonga proximal direction) so that it can fit within the outlet opening 248of the clip 240 (FIGS. 23A and 23D) when the tip 280A is secured to theclip 240. Thus, as fluids and/or other materials are discharged from theindividual conduits 251A-250C into the collection chamber 277 at thedistal end of the clip 240, they can be directed into the tip inlet282A.

In addition, according to some arrangements, the tip 280A comprises aplurality of ribs 286A or other reinforcing members along its outersurface. The ribs 286A can be configured to enhance the structuralintegrity of the tip 280A, enhance the appearance of the tip 280A and/orfacilitate handling of the tip 280A (e.g., attaching or removing the tipto or from the adjacent portion of the handpiece assembly 200). Further,the tip 280A may include one or more other functional or aestheticfeatures, as desired or required. Additional embodiments of disposabletips 280B-280E configured to receive a needle 290 and to connect to theclip 240 or other portion of the handpiece assembly 200 are illustratedin FIGS. 29A-32E. As shown, the shape, size and/or other designconsiderations of the tips 280B-280E can be modified, as desired orrequired. For example, the quantity, shape, size, method of connectionand/or other details of the tip inlet, tip outlet ribs and othercomponents of the tip can modified according to the individual needs orpreferences of particular clinician or other user of the injectionsystem.

In some embodiments, as illustrated in FIGS. 33A and 33B, the tip 280includes a backflow prevention valve or device 288, such as, forexample, a duckbill valve, another type of check valve and/or the like.Such a valve 288 can help ensure that fluids and/or other materials donot travel backwards through the tip 280 toward the clip 240 and/orother upstream components of the injection system. In other embodiments,the tip 280 comprises a combination duckbill-umbrella valve 288 that maypermit fluids and/or other materials to travel backwards toward the tipinlet 282 only under certain conditions. For example, as discussedherein with reference to aspiration procedures (FIG. 44), such acombination valve 288 may be configured to permit retrograde flow onlywhen a threshold vacuum force is applied to the tip inlet 282 (e.g.,when a syringe or other vacuum device is placed in fluid communicationwith the tip inlet 282). Thus, a combination valve 288 can help preventaccidental backflow of fluids and/or other materials toward the tipinlet 282 under typical operating conditions. Accordingly, the variousfluid and/or other streams being delivered through the handpieceassembly 200 can be maintained separate of each other upstream of such avalve 288 or other flow control device.

With continued reference to FIGS. 33A and 33B, the tip 280 can include aproximal portion 281A and a distal portion 281B attached thereto. Insome arrangements, a flow-regulating valve (e.g., duckbill valve, othercheck valve, combination duckbill-umbrella valve, etc.) is positionedwithin the tip's flow path generally between the proximal and distalportions 281A, 281B. A cross-sectional view of such an embodiment isprovided in FIG. 34. As shown, the valve 288 can be advantageouslypositioned immediately between the tip inlet 282 and tip outlet 284 sothat no fluids and/or other materials being conveyed through the tip 280can short-circuit the valve 288.

A cross-sectional view of one embodiment of a completely assembledhandpiece assembly 200′ is illustrated in FIG. 35. As discussed hereinwith reference to other arrangements, the core 210′ and the clip 240′can be secured to each other prior to using the assembly 200′. Further,as discussed, the core 210′ can be advantageously configured so that itdoes not contact any fluids and/or other materials flowing through thehandpiece assembly 200′. As a result, there is ordinarily no need toperiodically replace or clean the core 210′. Unlike the core 210′, theclip 210′ may be configured to be periodically replaced, as one or moreof its components (e.g., its internal coupling 270, the delivery line250, etc.) contact the fluids and/or other materials that are beingtransferred through the handpiece assembly 200′. According to somearrangements, the clip 240′ is replaced when the type, dosage and/orother characteristics of the fluids and/or other materials loaded intothe injection system are altered. The clip 210′ can also be replacedaccording to some predetermined time frequency, schedule, protocol orthe like, even when the characteristics of the medications or otherformulations being injected through the handpiece assembly 200′ are notmodified. In some embodiments, the clip 210′ is replaced together withthe cassette and the delivery line placing the cassette in fluidcommunication with the clip 210′.

With continued reference to FIG. 35, the handpiece assembly 200′ canadditionally include a tip 280′ that is removably secured to thecore/clip combination. For example, in the depicted embodiment, the tipattaches to the distal end of the clip 240′ and is placed in fluidcommunication with the delivery line 250 routed through the clip 240′.Moreover, as illustrated, a needle 290 can be configured to attach tothe distal end of the tip 280′. A threaded hub 294 of the needle 290 canbe configured to engage corresponding threads at the distal end of thetip 280′. In some embodiments, the hub 294 attaches to the distal end ofthe tip 280′ using a standard or non-standard luer lock connection.Alternatively, one or more other types of connection devices or methodscan be used.

The schematic of FIG. 36 illustrates one embodiment of fluids and/orother materials being conveyed through a handpiece assembly 200″. Asdiscussed in greater detail herein, medications and/or other substancesthat are desired for a particular injection procedure can be selectivelyand accurately delivered from a fluid delivery module to a downstreamhandpiece assembly 200″ via a delivery line 250. In some embodiments,the delivery line 250 comprises one, two, three or more differentconduits 251A-251C, each of which is in fluid communication with aparticular medication, other composition and/or the like that has beenloaded onto the fluid delivery module.

With continued reference to FIG. 36, once the delivery line 250 entersthe clip 240 of the handpiece assembly 200″, each of the variousconduits 251A-251C can be placed in fluid communication with a dedicatedbackflow prevention valve 376 (e.g., duckbill valve, other check valveor device, etc.) to prevent cross-contamination of the various conduits251A-251C and to prevent fluids and/or other materials from undesirablymoving in the reverse direction toward the fluid delivery module. Asshown, once fluids and/or other materials pass through the respectivevalves 276, they can enter into a common chamber 277. From there, suchfluids and/or other materials can be delivered to a desired anatomicallocation through a needle 290 positioned at the distal end of a tip 280.As shown, the tip 280 can include an internal passage that places theneedle 290 in fluid communication with the common chamber 277 of theclip 240.

In some embodiments, the tip 280 comprises a backflow prevention valve288 (e.g., duckbill valve, other check valve, etc.) that is configuredto prevent fluids and/or other materials from moving backwardstherethrough under normal operating conditions. In other arrangements,the valve 288 is configured to also permit flow in the reverse direction(e.g., from distal end of the tip 280 toward the clip 240) when a vacuumpressure applied to the tip inlet 288 reaches or exceeds a particularthreshold level. This can permit a user to aspirate a volume of fluidsand/or other substances from a desired anatomical location using the tip280 as an interface between the needle 290 and a vacuum-generatingdevice (e.g., syringe, pump, etc.). Additional details regarding suchaspiration procedures are provided herein with reference to the FIG. 44.

Depending on the types of medications, other fluids and/or othermaterials being delivered through the handpiece assembly during aninjection procedure, it may be desirable or necessary to ensure thatsuch formulations are sufficiently mixed before they are injected intothe anatomy. Thus, one or more internal conduits or other passages ofthe handpiece assembly can be adapted to provide such mixing. Forexample, in the schematic illustrated in FIG. 37, a clip 240′ comprisestwo individual conduits 251A, 251B that are placed in fluidcommunication with a common chamber 277′ located at or near the distalend of the clip 240′. As discussed, a clip 240′ can include more orfewer conduits as desired or required. Under certain circumstances, thefluids and/or other materials being conveyed through each conduit 251A,251B are traveling with sufficient velocity and energy that the twostreams will effectively mix with one another upon entering into thechamber 277′. However, in other arrangements, it may be desirable ornecessary to further enhance the mixing of the various fluids and/orother materials upstream of the needle 290′. For example, such mixingmay be helpful when the various fluid and/or other material streams havevarying physical (e.g., viscosity, density, affinity to water, etc.),chemical (e.g., pH) or other properties.

With continued reference to FIG. 37, the common chamber 277′ at or nearthe distal end of the clip 240′ can include a plurality of flowdiverters 289′ or other obstructions that extend into the flow path. Asa result, the various streams entering the chamber 277′ from each of theupstream conduits 251A, 251B can experience turbulent or substantiallyturbulent conditions, thereby facilitating the desired mixing. In someembodiments, the diverters 289′ or other flow obstruction members arearranged to direct the fluids and/or other materials entering the mixingzone M′ in a particular pattern. For example, the diverters 289′ can bearranged so the fluids and/or other materials passing therethrough areconveyed in a spiral or helical pattern. In one embodiment, the mixingzone M′ comprises a series of helices or other diverters 289′ that areskewed relative to each other. In other arrangements, the mixing zone M′includes a plurality of diverters 289′ (e.g., square or rectangularelements) that are shaped, spaced, oriented and otherwise configuredwithin the chamber 277′ to cause the fluids and/or other materialspassing therethrough to change direction (e.g., left and right, up anddown, etc.). Although specific examples of diverters 289′ and methods ofmixing the various streams are disclosed herein, it will be appreciatedthat the desired level of mixing may be accomplished in any othermanner.

In FIG. 38A, mixing of the various fluid and/or material streams occurswithin the tip 280″ of the handpiece assembly. This can advantageouslypermit the mixing zone M″ to be situated in a component of the handpieceassembly that is replaced between injection procedures. In the depictedembodiment, the mixing zone M″ is located immediately downstream of avalve 288″ (e.g., duckbill valve, combination duckbill/umbrella valve,etc.). However, the orientation of the mixing zone M″ relative to thevalve 288″ and/or any other component of the tip 280″ can be modified,as desired or required. As discussed herein with reference to FIG. 37,one or more diverters 289″ or flow obstructing or directing members canbe positioned within the mixing zone M″ to achieve the desired mixingscheme.

In other embodiments, as illustrated in FIG. 38B, the mixing zone M″′ isincluded within the needle assembly 290″′. For example, in FIG. 38B, thediverters 289″′ are positioned within the hub 294″′ portion of theneedle assembly 290″′ (e.g., immediately upstream of the needle 296″′).Such a configuration can eliminate the need to provide the required ordesired mixing within the tip 280, the clip 240 or other upstreamcomponent or portion of the handpiece assembly. As a result, the overalldesign of the handpiece assembly can be simplified. In addition, thecosts of providing a handpiece assembly configured to adequately mix thevarious fluid and/or other material streams passing therethrough can beadvantageously reduced.

Additional Handpiece Assembly Features/Alternative Designs

Other embodiments of a handpiece assembly are illustrated in FIGS.39-43B. The shape, size and/or other characteristics of the handpieceassembly can be modified to achieve a particular feel, comfort or otherfunctional objective. In addition, the configuration of the handpieceassembly can be modified for other functional and/or aesthetic reasons.

As illustrated in FIG. 38, a handpiece assembly 200A can include a sitelight 202 or other source of light to facilitate the clinician or otheruser during an injection procedure. In the depicted arrangement, thesite light 202 is positioned at the distal end of the handpiece assembly200A. However, the location, size, shape and/or other details of thesite light 202 can vary to suit a particular application or use. Inaddition, a handpiece assembly can include two or more site lights 202or other light sources, as desired or required.

As illustrated in FIG. 38, the handpiece assembly 200A can also comprisean optical ring 204 that is adapted to light up during an injectionprocedure. In some embodiments, each type of medication and/or otherformulation loaded within the fluid delivery module is associated with aparticular color. The color assigned to each medication or otherformulation (or a combination of two or more of such medications and/orformulations) can match or substantially match the color of a button222, 224, 226 or other control device (e.g., knob, switch, etc.) whichis positioned along the outside of the handpiece assembly (FIG. 22A) andis used to selectively regulate the transfer of such medication or otherformulation through the handpiece assembly.

In other embodiments, the color assigned to each medication or otherformulation (or a combination of two or more of such medications and/orformulations) generally coincides with a color assigned to thatmedication or formulation by the graphic user interface (FIGS. 48A-51)and shown on the display 130 of the fluid delivery module 100 (FIG. 2A).Accordingly, the optical ring 204 of the handpiece assembly 200A can beadapted to light up with the color of the medication or otherformulation (or a combination of two or more of such medications and/orformulations) being delivered through the handpiece 200A at anyparticular moment in time. Thus, the clinician or other user performingthe injection procedure can be continuously and conveniently informedabout what is being injected into the patient's anatomy.

As illustrated in the embodiment of FIG. 39, the optical ring 204 ispositioned near the distal end of the handpiece assembly 200A. Forinstance, the optical ring 204 can be positioned, either partially orcompletely, around the distal end of the core and/or clip portion.However, the optical ring 204 can be positioned in any other location ofthe handpiece assembly 200A, such as, for example, near the buttons 222,224, 226, at or near the proximal end of the assembly 200A or the like.Further, the optical ring 204 can have a different shape, size and/orother characteristic than illustrated in FIG. 39. For example, theoptical ring 204 can be a relatively small light having a circular,oval, rectangular or any other shape (e.g., similar to the indicatorlight 228 illustrated in FIG. 22A). Moreover, the optical ring 204 maycomprise LEDs, fiberoptics and/or any other technology to permit it toemit one or more colors. In other embodiments, the handpiece assembly200A comprises a small display (e.g., LCD) that provides the name of themedication or formulation (or combination thereof) being conveyed and/orany other information regarding the injection procedure being performed.

Although the site light 202 and the optical ring 204 are discussed withspecific reference to FIGS. 38 and 39, those of skill in the art willappreciate that one or both of these features (or equivalents thereof)can be provided on any other handpiece assembly disclosed herein.Therefore, the handpiece assembly 200 discussed herein with reference toFIGS. 21A-26C can be modified to incorporate one or more site lights 202and/or optical rings 204, as desired or required.

Another embodiment of the handpiece assembly 200B is provided in FIG.40. The depicted assembly 200B is generally similar to otherconfigurations disclosed herein. However, the illustrated handpieceassembly 200B includes a larger outer diameter to facilitate handlingand manipulation during use. As discussed, the handpiece assembly 200Bcan also include one or more other ergonomic, functional and/oraesthetic features or advantages, as desired or required.

FIG. 41 illustrates yet another embodiment of a handpiece assembly 200Cadapted for use in an articular injection system. As shown, thehandpiece assembly 200C can have a pistol-shape with a lower handleportion 209. As with other arrangements disclosed herein, the depictedhandpiece assembly 200C comprises a tip 280 and a needle 290 along itsdistal end. Further, the assembly 200C can include a plurality ofbuttons 222, 224, 226 that help the user control one or more aspects ofthe operation of the injection system. In some embodiments, thehandpiece assembly 200C comprises one or more triggers 208 (or otherbuttons, levers, knobs or the like) that are adapted to help regulatethe operation of the injection system (e.g., deliver one or more fluids,make selections on the display of the fluid delivery module, etc.). Sucha trigger 208 can be strategically positioned to allow a user toconveniently manipulate it with his or her index finger while graspingthe lower handle portion 209.

With continued reference to FIG. 41, the handpiece assembly 200C caninclude a tip release button 206 strategically positioned along itsouter surface. In some embodiments, pressing the release button 206causes the tip 280 to detach from the remainder of the handpieceassembly 200C (e.g., the clip). Thus, the tip 280 can be conveniently,quickly and safely discarded after an injection procedure. The shape,size, location and/or other details of the tip release button 206 can bedifferent than illustrated herein. In addition, such a release button206 for the tip 280 or any other portion of the handpiece assembly 200can be included in any other embodiment of a handpiece assemblydisclosed herein or equivalent thereof.

FIG. 42 illustrates an exploded side view of a handpiece assembly 200Daccording to a different arrangement. Like the handpiece assembly 200 ofFIGS. 21A-26C, the depicted embodiment includes a core 210D, a clip 240Dand a tip 280D that can be separated from each other.

The handpiece assembly 200E illustrated in FIGS. 43A and 43B includes aproximal main portion 210E and a distal tip portion 280E that areconfigured to removably attach to each other. As shown in FIG. 43A, themain portion 210E can comprise one or more passages 212E through whichfluids and/or other materials can be selectively transferred. Forexample, such passages 212E can be placed in fluid communication withone or more components of an articular injection system (e.g., acassette, a fluid delivery module, a delivery line, etc.). In someembodiments, as illustrated in FIG. 43B, the tip portion 280E includesone or more conduits 282E that are sized, shaped and otherwiseconfigured to mate with the passages 212E when the tip portion 280E isproperly secured to the main portion 210E. Thus, fluids and/or othermaterials can be conveyed through the passages 212E and the conduits282E toward a needle 290E positioned at the distal end of the tipportion 280E. In some arrangements, the passages 212E, the conduits 282Eand/or any other portion of the handpiece assembly 200E that may incontact with the fluids and/or other materials passing therethrough areconfigured to be replaced between injection procedures or in accordancewith some other protocol or schedule.

Aspiration

As discussed, any of the configurations of the articular injectionsystem and its various components disclosed herein can be adapted toalso aspirate fluids and/or other materials from the anatomy. Oneembodiment of a tip 280′ designed to be used during both an injectionprocedure and an aspiration procedure is schematically illustrated inFIG. 44A. For example, such a tip 280′ can be positioned at the distalend of a clip 240 or other portion of a handpiece assembly 200 (FIGS.21A and 21B). Thus, fluids and/or other materials can be conveyed fromthe clip 240, through the tip 280′ and into a needle 290 secured to thedistal end of the tip 280′. As discussed, the various configurations ofan injection system disclosed herein can advantageously permit two ormore different types of medications and/or other formulations to bedelivered into the anatomy (e.g., intra-articular location) with only asingle needle penetration. This can facilitate the injection procedureand reduce the pain and discomfort for the patient.

In some arrangements, the same tip 280′ can be utilized when fluidsand/or other materials need to be removed from the anatomy. In theschematic of FIG. 44A, a needle 290 is secured to the outlet 284′ of thetip 280′. As shown, with the distal end 291 of the needle 290 accuratelypositioned through a patient's skin S and within a target anatomicallocation T, the tip 280′ can be separated from the proximal components(e.g., clip, core, etc.) of the handpiece assembly 200. In someembodiments, as discussed herein with reference to FIG. 41, thehandpiece assembly includes a release button 206 to facilitate isolationof the tip 280′. Alternatively, the tip 280′ can be manually removedfrom the clip or other components of the handpiece assembly (e.g., byturning, pulling or otherwise moving the tip 280′ relative to the clip).

In some embodiments, the tip 280′ comprises a combinationduckbill/umbrella valve 288′ or other type of flow control device thatis configured to permit flow in both directions under certaincircumstances. As a result, fluids may not be permitted to beprematurely removed from the anatomy through the tip inlet 282′ when thetip is separated from the proximal portions of the handpiece assembly.When the clinician or other user is ready to aspirate fluids and/orother materials from the target anatomical location (e.g., joint), he orshe can attach a vacuum source V to the tip inlet 282′. The vacuumsource V can comprise a syringe, a pump and/or the like (e.g., amechanical, pneumatic or other type of device). In the illustratedembodiment, the tip inlet 282′ is sized, shaped and otherwise configuredto receive a distal tip D of a standard syringe V. For example, the tipinlet 282′ and the distal tip D of the syringe V can be connected usinga luer connection, another type of threaded connection or the like. Oncethe syringe or other vacuum source V is properly attached to the tipinlet 282′, a suction force can be generated at the tip inlet 282′(e.g., by pulling the inner plunger of the syringe rearwardly relativeto the outer barrel, by activating a pump or other device, etc.). If thesuction force meets or exceeds a particular threshold, fluids and/orother materials from the distal end 291 of the needle 290 can bepermitted to pass through the valve 288′. Accordingly, such fluidsand/or other materials can be advantageously removed form the anatomy.

In other embodiments, the tip 280′ can be configured to permitaspiration of fluids and/or other materials from the anatomy withouthaving to disconnect the tip 280′ from the clip, core or any otherproximal portion of the handpiece assembly. For example, the tip 280′can include a side branch that is in fluid communication with the mainfluid passage connecting the tip inlet 282′ and tip outlet 284′. Such abranch can include a flow control valve that is configured to preventflow therethrough when fluids and/or other materials are being injected,while allowing fluids and/or other materials to be removed from theanatomy when a vacuum source (e.g., syringe, pump, etc.) is connectedthereto. In some embodiments, such a branch terminates at the side ofthe tip 280′ with a luer connection, other threaded connection and/orthe like.

D. Injection System with Imaging

In some embodiments, an articular injection system 10 can be configuredto locate a targeted intra-articular or other anatomical site beforedelivering fluids thereto (or aspirating fluids therefrom). According tosome embodiments, a target anatomical location can be located using oneor more imaging, scanning and/or other locating devices or techniques.For example, as discussed in greater detail herein, an ultrasound devicecan be used to locate the targeted intra-articular space or otheranatomical location prior to transferring medications, fluids and/orother materials to or from a handpiece assembly 200. In someembodiments, the ultrasound device, radio frequency spectroscopy deviceor other locating apparatus can be connected to and/or configured towork in combination or otherwise interface with a fluid delivery module.

FIG. 45 illustrates an embodiment of an injection system 10 thatcomprises imaging devices or components that are configured to assist inlocating a target anatomical location. As shown, the fluid deliverymodule 100 can include a cassette 300 that is adapted to receive one ormore vials 400 or other containers. As discussed with reference to otherembodiments herein, such vials 400 can comprise anesthetics (e.g.,Lidocaine), other pain-relieving medications, steroids (e.g.,Depo-Medrol®, methylprednisolone acetate, etc.), hyaluronic acid,saline, pharmaceutical compositions, other medications or drugs, cells,liquid and non-liquid fluids and flowable materials, nanoparticles,cement, microbeads and/or any other material. In addition, as with otherembodiments disclosed herein, the cassette 300 or another portion of thefluid delivery module 100 can be in fluid communication with a handpieceassembly 200 that is configured to transfer one or more fluids and/orother materials to and/or from a targeted anatomical location with asingle needle penetration.

As discussed, the articular injection system 10 can comprise ultrasound,radio frequency spectroscopy or other imaging capabilities. For example,the fluid delivery module 100 can be in data communication with anultrasound wand 500 and/or any other component or feature of an imagingsystem. As illustrated in FIG. 45, the processors and other componentsthat enable the fluid delivery module 100 to comprise the desiredimaging capabilities can be generally incorporated within the wand 500and/or the fluid delivery module 100. However, in other embodiments,one, some or all of the necessary components of the imaging system areincluded in other devices or other components of the injection system10. Such separate devices can be adapted to be selectively placed intoand out of data communication with the fluid delivery module 100 usingone or more connection devices or methods (e.g., hardwired connections,wireless connections, etc.). For example, as discussed in greater detailherein, a core 210 or other portion of a handpiece assembly 200 caninclude buttons, other controller, circuitry, processors and/or otherelectrical and control features that are configured to regulate theoperation of an ultrasound device or other imaging system.

With reference to FIG. 45, the ultrasound wand 500 can be connected tothe fluid delivery module 100 using a cord 520 or other hardwiredconnection. However, as discussed, the wand 500 can be configured tocommunicate with the fluid delivery module 100 wirelessly (e.g., usingRF, Bluetooth and/or the like). As shown, the connection cord 520 can beinserted into a port 140 positioned along the outer housing of the fluiddelivery module 100.

A detailed perspective view of the ultrasound or other imaging wand ofFIG. 45 is provided in FIG. 46. As shown, the wand can include a mainbody 510 and a head 514 that is configured to contact the patient's skinduring the imaging procedure. In addition, the wand 500 can include aplurality of buttons 504, 506, 508, knobs, levers, switches and/or othercontrollers that allow the clinician to operate one or more aspects ofthe imaging system and/or the injection system. For example, the buttons504, 506, 508 can be configured to adjust or capture an ultrasound orother type of image. In some embodiments, the buttons 504, 506, 508 areconfigured to regulate the injection of fluids and/or other materialsthrough the handpiece assembly 200. Thus, the clinician or other usercan control all aspects of a procedure through a single device.Alternatively, the handpiece assembly 200 can include the buttons, knobsand other adjustment devices that are necessary to control both thedelivery of fluids and/or other materials through the handpiece assembly200 and the operation of an imaging system. As discussed, this canadvantageously permit a user to locate a targeted anatomical space(e.g., a joint), control the delivery of one, two or more differentfluids and/or substances to such a targeted space and/or regulate one ormore other aspects of an injection procedure without having to removehis or her hands from the handpiece assembly. In other embodiments, boththe injection and imaging systems are controlled by buttons or otheradjustment devices located on the fluid delivery module 100 (e.g.,touchscreen display), another portion of the injection system and/or aseparate device, either in lieu of or in addition to buttons located onthe handpiece assembly and/or the imaging wand 500.

Incorporating imaging technologies (e.g., ultrasound, radio frequencyspectroscopy, CT, MRI, etc.) into an articular injection system 10 thatis also configured to selectively transfer fluids and/or other materialsinto or out of a targeted anatomical location can facilitate theinjection/aspiration procedures for a clinician or other user. In someembodiments, an imaging-enabled injection system 10 can facilitateexecution of a particular injection procedure. In addition, such systems10 can enable an injection procedure to be completed with fewerclinicians and other resources. For example, when a separate imagingdevice is utilized, two or more physicians or clinicians are typicallyneeded to properly and safely complete the procedure. As illustrated inthe embodiment of FIG. 47, a clinician or other user can perform aninjection procedure by manipulating an imaging (e.g., ultrasound, radiofrequency spectroscopy, etc.) wand 500 in one hand to locate thetargeted anatomical location (e.g., toe, foot, knee, other joint, etc.),while simultaneously handling the handpiece assembly 200 in the otherhand to selectively transfer fluids or other materials to (or from) suchlocation.

Consequently, incorporating imaging technologies into the articularinjection system 10 can offer a number of advantages. For example, sucha combination unit can be operated using a single power supply. Inaddition, such a configuration can be operated using a single logicboard, computer chip or other processor. Further, as discussed, thecombination unit can allow a clinician to use “multi function” buttonsand controls. For instance, a button, soft key or other adjustmentdevice can be used to control both an ultrasound unit (or other imagingor location device) and the injection system.

As discussed, in any of the embodiments disclosed herein, a targetintra-articular location or other anatomical space can be located usingone or more imaging techniques, such as, for example, ultrasound,fluoroscopy, CT, MRI and/or the like. Ultrasound technology uses soundwaves of a particular frequency to image internal structures (e.g.,tissue, organs, joints, etc.). In some arrangements, pulsed and/orcontinuous sound waves can be directed to the area of interest using oneor more transducers. Redirected sound waves that bounce off anatomicalstructures are detected by the transducers or other devices (e.g., thewand 500 of FIG. 45). These data can then be processed to generate animage or other visual display of the targeted area.

Ultrasound transducers and other components used to locate a desiredanatomical location can be directly or indirectly incorporated into afluid injection system. For example, in some embodiments, a separateultrasound probe or wand is used to visually confirm the location of theneedle relative to the target location (e.g., an intra-articular space).The ultrasound equipment can be configured to operate eithercontinuously or intermittently during the course of the procedure, asdesired or required. In other embodiments, an ultrasound transducerand/or other ultrasound devices is incorporated directly into one ormore components of an injection system. For instance, a small ultrasoundtransducer can be positioned at or near the tip of the delivery oraspiration needle. The ultrasound transducer can be placed in datacommunication with a processing apparatus and/or other components usingone or more hardwired and/or wireless connections. In addition, theinjection system can be configured so that the imaging results areadvantageously viewed on the display 130 of the fluid delivery module.

Thus, as the needle is inserted into the body, a physician or otherclinician can accurately detect the position of the distal end of theneedle. Such imaging techniques can be used alone or in conjunction withone or more other locating methods or devices. For example, in oneembodiment, tissue response measurements can be used to locate a targetintra-articular space. In other embodiments, ultrasound and/or otherimaging technologies are used to locate a targeted intra-articularspace. In other embodiments, both tissue response measurements andultrasound and/or other imaging technologies are used to locate a jointspace. In still other embodiments, one or more other joint locatingmethods or devices can be used, either in lieu of or in addition tomethods, systems and methods disclosed herein.

In one embodiment, ultrasound imaging is particularly advantageousbecause it permits real-time visualization of a joint or other targetlocation. By way of example, in one embodiment, the delivery module andsystem include an ultrasound device using a broadband curved arraytransducer working at about 2-5 MHz and a broadband linear array workingat about 4-7 MHz. Imaging errors can be kept at a minimum by taking thelinear array for measurements. Curved array may be desirable and usedfor better penetration depth.

The use of ultrasound to guide injection of fluid into small jointspaces is particularly useful. Researchers have used ultrasound guidefor the aspiration of fluid from joint spaces (see Ultrasound guidanceallows accurate needle placement and aspiration from small joints inpatients with early inflammatory arthritis, Rheumatology 2003; 42:976-979, herein incorporated by reference). However, several embodimentsof the present invention provide a system and method of using ultrasoundguidance to inject fluids into small joint spaces.

Ultrasound can assist in the visualization of internal structures (e.g.,bones, joints, organs, other tissue, etc.) within the anatomy. As such,ultrasound technologies can be used to visually display the orientationof the needle with respect to such internal structures. Consequently,ultrasound can assist a user in correctly positioning and directing theneedle during an injection and/or aspiration procedure.

In addition, a contrast media can be used with the ultrasound devicesand methods described herein to further enhance the user's ability toverify the location of the needle tip relative to the targetedanatomical location (e.g., intra-articular location, organ, etc.). Thiscan provide additional assurances that the medication, other fluidand/or other substances are being delivered to the desired locationwithin the patient being treated. A contrast media can also be used inembodiments where aspiration of a fluid or other material is desired.For example, if acceptable, a contrast media can be delivered to or nearthe desired location. Then, once placement of the aspiration needle hasbeen confirmed, the fluid module can be used to aspirate as required. Insome embodiments, if the aspiration procedure is therapeutic in nature(e.g., being used to relieve pressure within the targeted anatomicallocation), the use of contrast media may be acceptable. However, in oneor more other circumstances, the use of contrast media may not beacceptable or desirable. For example, if the purpose of the aspiratingis to withdraw a fluid for diagnostic reasons (e.g., testing theextracted fluid sample), initially injecting a contrast media or othersubstance may contaminate the desired sample.

The incorporation of an ultrasound or other imaging device or systeminto an injection system can provide additional benefits to a facility,a clinician or other user. In some arrangements, such a configurationhelps with the generation of accurate reports for billing, recordkeepingand/or other purposes. For example, data regarding which ultrasoundand/or other imaging devices or systems were utilized and to what extentthey were used during a particular injection procedure can beautomatically stored within a memory (e.g., hard disk, other fixed orremovable drive, etc.) of the fluid delivery module or other componentof the injection system (or other system operatively connected to theinjection system, e.g., a separate computer, processor and/or the like).Consequently, such accurate information can be retrieved and processedto generate bills or other summaries of work performed. Thus, a providercan accurately charge and be reimbursed for the ultrasound or otherimaging technology utilized in a particular procedure.

Further, ultrasound or other imaging technologies can be incorporatedinto an articular injection system for evidentiary purposes. Forinstance, physicians, other clinicians, their employers, the facilitiesin which such injection procedures are executed, insurance companiesand/or any other interested parties can be provided with an accuratesummary of an entire injection procedure. Information that can be savedmay include, without limitation, the date, time and duration of aprocedure, the name(s) of the patient, physician, clinician or otherparty executing or assisting with the execution of the procedure, thesteps taken to locate a joint or other target location, the amount ofeach medicament or other substance delivered into a patient, thesequence, flowrate and other details related to the delivery of thevarious injected materials and/or the like. In addition, ultrasound orother images captured during the procedure can also be saved for laterprocessing or retrieval. In some embodiments, time-sequential images canbe captured and saved prior, during or following the various steps of aprocedure (e.g., locating a joint or other anatomical location,injecting a first fluid or other substance, injecting a second oradditional fluids or other substances, removing the needle, etc.). Thiscan be particularly useful when color Doppler or other technologies areused that permit for the various fluid and/or material streams to bevisually distinguished.

In some embodiments, such data collection is important to determinewhether a patient has satisfied certain prerequisites for subsequenttreatment procedures. For instance, certain health insurance plans ormanaged care organizations (e.g., HMOs) require that a subscriberundergo certain preliminary procedures (e.g., injections) beforebecoming eligible for more expensive and complicated treatments, suchas, for example, surgery.

E. Graphic User Interface

According to some embodiments, the display 130 on the fluid deliverymodule 100 or any other component of the system 10 (FIG. 2A) can beadvantageously configured to facilitate the user in customizing andexecuting a particular injection procedure. For example, the display 130can include a touchscreen that is adapted to provide information to andreceive instructions from a clinician or other user. In otherarrangements, the fluid delivery module 100 and/or another component ofthe injection system 10 can include a data input device (e.g., a keypad,keyboard, etc.) that is separate from the display 130.

The various embodiments of an injection system disclosed herein can beconfigured to selectively deliver one, two, three or more differentmedications, formulations and/or the like into a targeted anatomicallocation. In some arrangements, such fluids and/or other materials aredelivered simultaneously (e.g., mixed with one another) during delivery.Alternatively, such fluids and/or other materials can be deliveredsequentially, according to some predetermined sequence or protocol, asdesired or required. As discussed with reference to FIGS. 22A and 22B,the handpiece assembly 200 of the injection system can include one ormore buttons 222, 224, 226, levers, knobs and/or other control featuresto allow the user to regulate the transfer of fluids to the distal endof the needle 290. For instance, each button 222, 224, 226 can beconfigured to control the delivery of a medication, formulation or otherfluid or material from a corresponding vial 400 or other containerloaded onto the fluid delivery module 100. As discussed in greaterdetail herein, a button 222, 224, 226 can be adapted to simultaneouslydeliver the contents of two or more vials 400 or other containers.

FIGS. 48A-48D illustrate various screenshots 600A-600D of a touchscreendisplay 130 of the fluid delivery module 100 that can be advantageouslyconfigured to permit a clinician or other user to control the deliveryof the medications and/or other fluids or materials loaded onto thefluid delivery module. In the embodiment illustrated in FIGS. 48A-48D,the fluid delivery module is adapted to receive up to three vials orother containers, the contents of which may be selectively deliveredthrough a handpiece assembly as described in greater detail herein.However, in other embodiments, the articular delivery system may includemore or fewer vials or other containers, as desired or required.

With reference to the screenshot 600A illustrated in FIG. 48A, thetouchscreen display can provide flowrate and other data for each type ofmedication, formulation and/or other fluid or material loaded onto thefluid delivery module. For example, the contents of the vial or othercontainer positioned on a first nest or loading area of the fluiddelivery module (and subsequently placed in fluid communication with thehandpiece assembly as discussed herein) can correspond to one of thenumbered headings 604, 606, 608 depicted on the display. As discussed ingreater detail herein, these numbered headings 604, 606, 608 can alsocorrespond to the buttons 222, 224, 226 or other controllers provided onthe handpiece assembly 200 or other component of the injection system(FIGS. 22A and 22B).

In some embodiments, other information about the fluids and/or othermaterials that are loaded within a fluid delivery module can be providedon the screenshots 600A-600D. For example, information about the name ofthe composition and/or other fluid or material can be provided. In otherarrangements, a code (e.g., NDC) and/or other identifier about theparticular medication or formulation loaded onto the fluid deliverymodule can be displayed. Further, as discussed with reference to FIGS.19A-19C, the vials 400 or other containers being secured to the fluiddelivery module can be configured to be automatically or manuallyidentified (e.g., using an identification flag 460 or other membersecured to a vial adapter 450D, using a barcode scanner or otheridentification device positioned along the outside of the fluid deliverymodule, etc.). Thus, information detected by these types of devices(e.g., type of medication, dosage or concentration, manufacturer,expiration date, etc.) can be advantageously provided on the display ofthe fluid delivery module. In addition, other data or other informationcan also be included on the display, such as, for example, imaging datafor locating the distal end of the needle, date, time, name of thepatient, name of the physician or other clinician performing theprocedure and/or the like, as desired or required.

With continued reference to FIG. 48A, the touchscreen display caninclude up and down arrows 634A, 634B, 636A, 636B, 638A, 638B associatedwith each type of medication, formulation and/or other fluid ormaterial. Thus, a clinician or other user can select the volume, massand/or other amount of a particular substance that should be deliveredwithin a targeted anatomical location for an injection procedure. Thevolume or other amount selected at any particular time can be displayedin a corresponding area 624, 626, 628 of the display. In addition, thetotal 620 volumetric or other amount of fluids and/or other materials tobe delivered within an anatomy for a particular injection procedure canalso be displayed.

By way of example, in FIG. 48A, the user has selected to inject 2.0 cc,5.0 cc and 5.0 cc of a first, second and third medication or otherformulation, respectively. Thus, as shown, the total volume of fluids tobe delivered during this procedure is 12.0 cc (e.g., displayed onsummation window 620). Further, the touchscreen display can offer aconvenient way of modifying a particular protocol using the up and downarrows 634A, 634B, 636A, 636B, 638A, 638B. As illustrated, a screenshot600A of the touchscreen display can include one or more softkeys orother buttons (e.g., “MENU” “OK”, etc.) that enable a user to inputdesired settings (e.g., maneuver through the various screens) and/oradjust the details associated with a specific injection procedure.

Once the details of a desired injection protocol have been entered, auser can use the buttons 222, 224, 226 or other control devicespositioned along the exterior of the handpiece assembly 200 (FIGS. 22Aand 22B) or other component of the system to selectively deliver one ormore of the medications, formulations and/or other fluids or materialsto a patient. For example, in one arrangement, a physician or other userpresses a button 222 of the handpiece assembly 200 to deliver theinternal contents of a first vial or other container secured to thefluid delivery module. In the depicted screenshot 600A, the button 222that is assigned to control the delivery of such fluids and/or othermaterials can be generally represented by a number 604 (e.g., “1,” “2,”or “3”). Such a number or other identifier (e.g., shape, color, graphic,etc.) can match or substantially match the number or other identifier onor near the corresponding button 222 of the handpiece assembly. Thus, aclinician or other user can easily determine which button 222, 224, 226or other controller of the handpiece assembly 200 is used to deliver aparticular medication, formulation and/or other fluid or material.

In order to stop delivering such a fluid or other material to thepatient, the physician can release the corresponding button 222 or othercontroller (or press such a button 222 again). In some embodiments, theamount of a medication or other formulation is not permitted to exceedthe amount selected using the corresponding up and down arrows 634A,634B and displayed in the corresponding area 624 of the display. Otherbuttons 224, 226 of the handpiece assembly 200 can be manipulated toselectively deliver other fluids and/or materials (e.g., generallycorresponding to buttons “2” and “3” on FIG. 48A).

Accordingly, the screenshot information provided on the display can beused to control the manner in which medications, formulations and/orother fluids or materials are delivered to an articular space or otheranatomical location. As discussed herein with reference to FIGS.49A-49D, the display can change to a different screenshot during thedelivery of the various fluids and/or other materials. Thus, in somearrangements, the screenshots 600A-600D illustrated in FIGS. 48A-48D areprimarily used to enter the details regarding a desired injectionprocedure.

In some embodiments, two or more medications, formulations and/or otherfluids or materials can be combined and delivered together through thehandpiece assembly by pressing a single button 222, 224, 226 of thehandpiece assembly 200. For example, the fluids and/or other materialsassociated with buttons “1” and “2” 604, 606 in FIG. 48A can beconcurrently delivered to a targeted anatomical location by activating asingle button (e.g., button “1”) of the handpiece assembly 200. In someembodiments, a user can use the “MIX” buttons 614, 616, 618 of thetouchscreen display to program the injection system so that two or moremedications or other formulation are concurrently delivered using asingle button 222, 224, 226 or other controller.

With continued reference to FIG. 48B, once a user chooses to deliver twoor more different medications, formulations and/or other fluids ormaterials using a single button or other controller, the display can beconfigured to visually assign a single button number 605 (e.g., “1”) tosuch a combination. Further, the windows 624, 626 or other portions ofthe screenshot 600B displaying the volume or other amount of thecorresponding medications, formulations and/or the like can be visuallycombined (e.g., using a larger window or area 625) in order to make itclear that such materials will be delivered simultaneously.

According to some embodiments, the rate of delivery of the medications,formulations and/or materials being simultaneously delivered (e.g.,using a single button as illustrated in FIG. 48B) is adjusted so thatthe desired volumes or other amounts of such materials expire at thesame time for a particular injection procedure. In other words, in thearrangement of FIG. 48B, the rate of delivery of the first fluid can beslow relative to the rate of delivery of the second fluid so that the2.0 cc of the first fluid and the 5.0 cc of the second fluid are used upat the same time or approximately the same time during an injectionprocedure. Alternatively, the rate of delivery of the fluids and/orother materials that are simultaneously delivered through the handpiececan be adjusted so that one or some of the fluids or materials are usedup before the others.

FIG. 48C illustrates another screenshot 600C configured to be displayedon a touchscreen or other display of a fluid delivery module. In thedepicted embodiment, the clinician or other user has chosen to deliverthe second and third medications, formulations and/or other fluids ormaterials using a single button (e.g., button “2” of the handpieceassembly). The combination of such fluids and/or other materials isgenerally represented in the illustrated screenshot 600C by the numericlabel “2” 607. Thus, as discussed herein with reference to FIG. 48B,these fluids and/or other materials can be simultaneously delivered bythe clinician using a single button 222, 224, 226 of the handpieceassembly 200 that includes a corresponding numeric label (e.g., “2”) orother identifier (e.g., color, graphic, etc.).

In the embodiment depicted in FIG. 48D, the clinician or other user hasprogrammed the injection system so that all three medications,formulations and/or other fluids or materials loaded onto the fluiddelivery module are delivered using a single button 222, 224, 226 of thehandpiece assembly 200. In the illustrated arrangement, the simultaneousdelivery of all three fluids and/or other materials is generallyrepresented by numeric label “1” 603. Thus, by pressing and releasingthe corresponding button 222, 224, 226 of the handpiece assembly, a usercan selectively activate and deactivate delivery of all three fluidsand/or materials, respectively.

As discussed, in some embodiments, the display is configured to switchto an alternate screenshot once the injection procedure has beencommenced. Examples of such delivery screenshots 650A-650D areillustrated in FIGS. 49A-49D. Each screenshot 650A-650D shown in FIGS.49A, 49B, 49C and 49D generally corresponds with and follows theinjection setup screenshot 600A-600D shown in FIGS. 48A, 48B, 48C, 48D,respectively.

With reference to FIG. 49A, each fluid and/or other material loaded ontothe fluid delivery module can be represented by a syringe 664, 666, 668.In the illustrated embodiment, the volume or other amount of each typeof medication or formulation remaining within the cassette or otherportion of the fluid delivery module for injection into a patient isgraphically represented on the screenshot 650A. For example, eachsyringe 664, 666, 668 can be shown filled with the remaining volume offluids and/or other materials. As fluids and/or other materials aredelivered into an anatomy, a line 674, 676, 678 representing the distalend of a syringe plunger moves within the corresponding syringe 664,666, 668 (e.g., to the right as illustrated in FIGS. 49A-49D). As aresult, the amount of fluid remaining within the corresponding syringe664, 666, 668 decreases. Accordingly, the user is permitted toconveniently follow the status of the injection procedure.

As shown in FIGS. 49A-49D, the volume or other amount of each medicationor formulation can also be numerically displayed within correspondingwindows 684, 686, 688 of the screenshots 650A-650D. The screenshot mayalso include a window 690 displaying the total volume of fluids and/orother materials delivered into an anatomy during an injection procedure.In FIGS. 49B-49D, two or more types of medications or formulations arebeing delivered simultaneously by selectively manipulating a singlebutton 222, 224, 226 or other controller of the handpiece assembly 200.Thus, a single syringe 665, 667, 663 can be used to graphicallyrepresent such combined fluids and/or other materials.

With continued reference to FIGS. 49A-49D, the display can be configuredto display information regarding the pressure 696 at or near the distalend of the needle 290, either while the needle 290 is being delivered tothe target anatomical location (e.g., a joint) or while fluids and/orother materials are being delivered to such a location during the courseof an injection procedure.

According to some arrangements, in part for patient safety, the fluiddelivery module is configured to accurately measure and regulate theflowrate and/or pressure of a medication, fluid or other material beingdelivered to the target anatomical location. Thus, the system cancomprise pressure and/or flow measurement devices (e.g., pressuretransducers, flowmeters, etc.). Pressure sensing devices can be used toensure that the pressure or vacuum created by the discharge of themedications, compositions, fluids and/or other materials within theanatomy does not exceed a particular threshold level. This can helpprevent or reduce the likelihood of damage occurring to the patientbeing treated using the injection system. Such an internal forcemeasurement system can be configured to automatically shut off the fluidtransfer device (e.g., movement of the stepper motor, other pump, etc.)when the discharge pressure exceeds a maximum level (e.g., 3 psi). Inother arrangements, the fluid delivery module can include a visualand/or audible alarm or other similar feature to alert the user than athreshold pressure has been attained, either in lieu of or in additionto any automatic shut-off mechanism. For example, the clinician or otheruser can track real-time pressure and/or flowrate data on correspondingportions 696 of the display during an injection procedure. Other typesof feedback that indicates position or placement to a user may also beused (e.g., mechanical or tactile feedback). Such safety features can beincluded in any of the embodiments of the modules or systems disclosedherein.

Alternative embodiments of screenshots 700, 800 for a display of fluiddelivery module or other component of an injection system areillustrated in FIGS. 50A and 50B, respectively. As shown, thescreenshots 700, 800 can comprise various graphical and/or numericportions that are adapted to provide data and other information to theuser, either before or during an injection procedure. In addition, thedisplay can include softkeys, buttons and/or other data input devicesthat permit a user to adjust and customize an injection procedure asdesired or required.

FIG. 51 illustrates one embodiment of a screenshot 880 configured to beshown on a display of a fluid delivery module or other component of oroperatively connected to an injection system. As shown, the display canbe configured to simultaneously provide information regarding bothimaging and the injection of fluids and/or other materials. For example,an upper portion 884 of the screenshot 880 can be adapted to provide areal-time ultrasound image (e.g., to help locate a joint or other targetanatomical location). Further, a lower portion 886 of the screenshot 880can be adapted to provide information regarding the delivery of thevarious substances into the patient. Thus, a clinician can use a singledisplay of the fluid delivery module or other portion of an injectionsystem to execute an injection procedure. Further, in some embodiments,color Doppler technology can be used to permit a clinician or other userto visualize the various steps of an injection procedure in real time.As discussed in greater detail herein, such screenshots and other imagescan be saved for billing, recordkeeping and/or other evidentiarypurposes.

As discussed, in some embodiments, data and other information regardingthe types, volumes or other amounts, dosages and/or other details of thevarious medications and/or other substances administered during aparticular injection procedure, as displayed to the user in atouchscreen or other interface, are automatically stored within a memoryof the fluid delivery module, another component or portion of theinjection system or an external processor or network with which theinjection system is in data communication. In addition data andinformation related to ultrasound or other imaging procedures that wereconducted can also be saved for later processing (e.g., documentation,billing, etc.) or retrieval. Such data and information can includeactual ultrasound images, details regarding the imaging equipment used,the extent to which a particular imaging device was used and/or thelike. Systems incorporating such a feature can be facilitated by the useof automatically detectable vials or other containers (e.g., FIGS.19A-19C). In addition, as discussed, other details related to a specificprocedure can also be recorded, maintained and linked to a deliverysequence of various medicaments and/or other substances. For example,the injection system can be configured to receive and maintain the nameof the patient, the date and time that the procedure was performed, theduration of the procedure, the physicians, clinicians and/or otherpersonnel that participated in the preparation and/or execution of theprocedure, the disease or condition being treated, specific treatmentcodes and other administrative information and/or the like. Such datacollection capabilities can assist with billing, patient record keeping,generation of reports, reordering of medicaments and other injectablematerials and/or other functions.

F. Cart

FIG. 52 illustrates a cart 900 adapted to support an embodiment of anarticular injection system 10 disclosed herein or an equivalent thereof.As shown, the cart 900 can include a top shelf 910 that is sized, shapedand otherwise configured to receive a fluid delivery module 100, one ormore handpiece assemblies 200 and any other components of the system 10.In one embodiment, the cart 900 includes a docking station 914 that isconfigured to receive a handpiece assembly 200 for recharging andstorage when not in use. In addition, the cart 900 can include one ormore other shelves 926, drawers 930 and/or containers 910 (e.g., wastereceptacles for receiving spent needles, tips, etc.), as desired orrequired. The cart 900 can include one or more wheels 920 so that it canbe easily moved to various locations within a facility.

EXAMPLES

Non-limiting examples of injection procedures that may be performedusing the various embodiments of systems, devices and methods disclosedherein (or equivalents thereof) are provided below. It should be notedthat these examples are provided to simply demonstrate only some of thefeatures and/or other details of injection systems, devices and methodsdiscussed and illustrated herein. As such, the following examples or anyother portion of the specification or figures should not be used tolimit the present application in any manner.

Example No. 1

The flowchart in FIG. 53 schematically illustrates one non-limitingexample of a sequence 1000 for delivering medications, formulationsand/or other fluids or substances to a target anatomical site (e.g., ajoint, an organ, etc.) using an injection system in accordance with theembodiments disclosed herein. A touchscreen or other visual display of afluid delivery module or other portion of the system can be configuredto initially display 1010 a logo, the time, date, patient and/orphysician identifying information, hospital or facility name or logoand/or any other image, design or other alpha-numeric text. However, inother embodiments, such a display is configured to not display anythingat all. In fact, the fluid delivery module may not include a display atall.

With reference to FIG. 53, it may be necessary for a physician or otherclinician to prepare the system 1014 for the subsequent delivery offluids into a patient. For example, as discussed in greater detailherein, a cassette (or other portion of the fluid delivery module) maybe replaced. In some embodiments, used needles, tips, clips, deliverylines, other conduits and/or any other component or portion of thehandpiece assembly are removed and replaced with new components orportions. For example, the clinician or other user can secure anappropriately sized (e.g., length, diameter, etc.) sterile needle and/ortip to the distal end of the handpiece device.

As discussed, the needle and tip of the handpiece device can be replacedbetween injection/aspiration treatments or procedures. Thus, as isstandard practice in medical procedures, cross-contamination of fluidsbetween different patients can be prevented. Assuming that there is noneed to change the medications or other materials loaded within thedelivery module, replacement of only the needle and tip canadvantageously permit a physician or other user to quickly and easilyperform injection procedures in many different patients. For example, insome embodiments, a physician can perform injection procedures in 30-40or more different patients per day without having to replace the clip,core or any other portion of the handpiece assembly. Therefore, forpractical reasons, a clinician can dedicate a particular delivery moduleto a specific combination of medications or other substances so that heor she only needs to replace the tip and needle between uses.

In other embodiments, where the type, dosage or other characteristics ofthe medications or other substances secured within the loading area ofthe delivery module change, the clinician or other user may also berequired to replace the clip, delivery line or other conduits, cassetteand/or any component, subcomponent or portion of the injection systemthat may contact the medications, formulations and/or other fluids ormaterials being delivered within an anatomy. Thus, as discussed withrespect to the various embodiments disclosed herein, certain componentsand portions of the injection system (e.g., the handpiece assembly,fluid delivery module, etc.) can be advantageously configured to beeasily and quickly removed and replaced as desired or required (e.g.,between injection procedures, when the characteristics of themedications and/or other materials being injected are modified,according to some predetermined schedule, etc.). The foregoingdisclosure regarding the replacement of tips, needles, clips, deliverylines, other conduits and/or the like can be applied to any embodimentsdisclosed herein or variations thereof.

Once the injection system has been adequately prepped, the clinician canselect 1018 the details of the particular injection procedure to beperformed. For example, in some embodiments, the clinician uses theinteractive menus provided on a display of the fluid delivery module orother component of the system to choose one of various protocols alreadyrecognized by the injection system (e.g., saved within the memory of thefluid delivery module). In other arrangements, the clinician enters thedetails (e.g., types, volumes or other amounts, dosages and/or otherinformation) regarding the medications, formulations and/or othermaterials to be injected into a patient. Thus, a clinician or other usercan customize a particular injection protocol, as desired or required.In some embodiments, the injection system is configured to save thedetails of the various injection protocols, thereby allowing a clinicianor other user to access such information in the future (e.g., forpurposes of repeating the same injection protocol, for record keepingand/or for any other purpose). Such data and other information can beshared with another network (e.g., the hospital's or other faculty'smain network, the internet, etc.).

Next, the clinician or other user can secure 1022 one or more vialscontaining the medications, formulations and/or other fluids ormaterials that are needed to execute a particular injection procedure.For example, each vial or other container can comprise anesthetics orother pain-relieving medications (e.g., Lidocaine, other slow or fastacting anesthetics, etc.) steroids (e.g., Depo-Medrol®,methylprednisolone acetate, etc.), hyaluronic acid, saline,pharmaceutical compositions, other medications or drugs, cells, liquidand non-liquid fluids and flowable materials, nanoparticles, cement,microbeads and/or combinations of such fluids and other materials.

In some embodiments, the required vials or other containers are securedto a nest, loading area or other receiving area of the fluid deliverymodule (e.g., cassette). Alternatively, the vials can be positionedalong a different portion of the fluid delivery module or othercomponent of the injection system, as desired or required.

According to some arrangements, the vials or other containers secured tothe fluid delivery module or other portion of the system are verified1026 to confirm that the characteristics (e.g., type, dosage, volume,expiration date, etc.) of the medications, formulations and/or otherfluids or materials that will be delivered into a patient are inaccordance with the intended protocol. This can improve the safety andaccuracy of the injection procedure, as the likelihood of deliveringincorrect substances to a patient is advantageously eliminated orreduced.

Confirmation of the medications and/or other materials contained withinthe vials secured to the fluid delivery module or other portion of theinjection system can be performed manually or automatically. Asdiscussed herein with reference to FIGS. 19A-19C, adapters with flags oridentification members can be secured to the vials or other containers.As a result, when a vial is secured to the fluid delivery module, areader or other identification device can be configured to automaticallydetect the contents of such a vial. In other arrangements, the fluiddelivery module or other portion of the injection system comprises abarcode scanner, RFID reader or other device adapted to identify amachine-readable machine code (e.g., barcode or other textual code,color or graphical pattern, etc.) and/or the like. In still otherembodiments, the clinician or other user manually confirms the contentsof a vial or other container. For such systems, a user may be requiredto enter certain data and/or other information about the vials or othercontainers into one or more components of the injection system. Forinstance, a user can use a touchscreen, a keypad or keyboard or otherdata entry device to input the NDC, the name of the medication and/orany other information, to confirm the identity of the vials and/or thelike.

With continued reference to the example injection procedure that isschematically illustrated in FIG. 53, the clinician can then transfer1030 all or some of the medications, formulations and/or other materialscontained in the vials to an interior portion of the fluid deliverymodule or other component of the injection system. For example, asdiscussed in greater detail herein, the internal contents of such vialsor other containers can be conveyed to syringes or other reservoirswithin a cassette or other portion of the fluid delivery module. Oncewithin such syringes or other reservoirs, one or more of the variousmedications and/or other materials can be selectively administered intoa patient through a handpiece assembly.

However, before any medications and/or other materials can be injectedinto a patient, the needle at the distal end of the handpiece assemblymust be accurately positioned within the targeted anatomical location(e.g., joint, organ, etc.). In some embodiments, imaging techniques canbe used to locate 1034 such a joint or other targeted location.Alternatively, one or more other devices or methods can be used toaccurately position the needle within a patient's body. For example, asdiscussed herein with reference to FIGS. 45-47, the injection system cancomprise ultrasound, radio frequency spectroscopy and/or other imagingcapabilities to assist in accurately positioning the needle of thehandpiece assembly within the anatomy of a patient. Incorporatingimaging technologies (e.g., ultrasound, radio frequency spectroscopy,CT, MRI, etc.) into an injection/aspiration system can facilitate theinjection and/or aspiration procedures for a physician or otherclinician. For example, as noted herein, such injection systems canpermit a single user to conduct the entire procedure alone.

In other embodiments, locating the targeted intra-articular spacecomprises measuring one or more tissue characteristics at or near thetip or distal end of the needle being inserted into the anatomy. Eachtype of intra-articular space can be associated with a particular tissueresponse range within which the tissue response value at the distal endof the needle should be. Thus, as the needle is advanced through skin,subcutaneous tissue and/or other anatomical layers, the tissue responsevalue at or near the tip of the needle may fluctuate. In one embodiment,the tissue response value at the needle tip decreases as the needleenters into the desired intra-articular space. Therefore, the system canbe configured to instruct the user to advance the needle until thetissue response value drops below a specific threshold level.

In some embodiments, an optical fiber, electrode or other type ofsensing device can be located at or near the distal end of the needle. Aprocessor of the delivery module can be programmed or otherwiseconfigured so when a tissue response value is measured, received ordetected by the corresponding sensor (e.g., optical fiber, electrode,etc.), the fluid delivery module can determine whether the targetedanatomical area has been reached. The delivery module can be configuredto indicate relevant information regarding the needle's position usingone or more devices, components or methods, such as, for example, viathe touchscreen or other display (e.g., visual readouts, charts, etc.),via audible indicia (e.g., tones, voice commands, etc.) and/or the like.

A display of the fluid delivery module (e.g., touchscreen, LCD screen,other monitor, etc.) can be configured to provide a textual and/orgraphic representation of the tissue response value, its rate of changeand/or any other details related to locating an intra-articular space.For example, the tissue response value at or near the tip of the needlecan be displayed as the actual value (as text) or as a chart or graph(e.g., X-Y plot, a circular target chart, etc.).

After the needle has been properly positioned within a patient, theclinician can initiate delivery 1038 of one or more medications,formulations and/or other fluids or materials, as required by aparticular injection protocol. As discussed, the clinician can use thebuttons or other controllers on the handpiece assembly or other portionof the injection system to accurately control the delivery of aparticular fluid or material stream into the patient. For example, insome arrangements, the clinician initiates delivery of Lidocaine oranother anesthetic. As discussed, the delivery of such anesthetics canbe initiated as the clinician begins to advance the needle through thepatient's anatomy or after the tip of the needle has been accuratelypositioned within a joint or another targeted anatomical location (e.g.,muscle tissue, organ, etc.).

The incorporation of mechanically, hydraulically, pneumatically ordifferently driven delivery of medications, formulations and/or otherfluids or materials from the fluid delivery module to the patient canfacilitate the execution of an injection procedure. For example, aphysician or other clinician can simply use one or more buttons or othercontrollers (e.g., on the handpiece assembly, touchscreen of fluiddelivery module, imaging wand, etc.) to accurately deliver a volume orother amount of a particular substance to a joint or another targetedanatomical location. This can be particularly helpful when the manualdelivery of such fluids and/or other materials could be difficult,strenuous, repetitive or otherwise problematic. A relatively high andpersistent force and effort may be required by the physician or otherclinician to deliver one or more medicaments and/or other substances toa targeted anatomical location. This can be particularly problematicwhen attempting to inject dense, viscous or high-solids fluids or othermaterials to small joints (e.g., toes, fingers, midfoot joints, etc.) oranother high back-pressure locations within an anatomy (e.g., to or nearbones, certain organs, etc.). Thus, at least some of the embodiments ofthe injection systems, devices and methods disclosed herein permit thedelivery of one or more medicaments and/or other materials from a fluiddelivery module to a target anatomical location within a patient withoutthe need to push or exert the necessary force or effort to physicallyadminister such substances. Consequently, the clinician or other usercan dedicate more of his or her time and effort in accurately locating ajoint or other targeted anatomical location and executing the desiredinjection procedure.

As discussed, the clinician can selectively deliver 1042 one or moreother fluid and/or material streams into a patient, either alone orconcurrently with the delivery of another stream. In some embodiments,this is accomplished by pressing or otherwise manipulating buttons orother controller on the handpiece assembly or another portion of theinjection system. Further, the injection system can be configured sothat operation of such a button or other controller causes two or moredifferent fluid and/or material streams to be simultaneously deliveredthrough the needle. Screenshots (FIGS. 48A-51) visually provided on adisplay or other output device can assist the clinician with selectingan injection protocol and/or executing an injection procedure.

According to one embodiment, a procedure comprises the injection of avolume of an anesthetic and/or a steroid (Depo-Medrol®) after a volumeof a first medication (e.g., Lidocaine or another anesthetic orpain-relieving medication) has been injected into the targeted area. Inother arrangements, one or more other fluids and/or other materials(e.g., hyaluronic acid, saline, pharmaceutical compositions, cells,nanoparticles, cement, microbeads, etc.) can be contained within one ormore of the vials or other containers loaded onto the cassette or otherportion of the fluid delivery module, either in lieu of or in additionto the anesthetics, pain-relieving medications and steroids, as requiredor desired. According to some embodiments of injection modes orsequences, two or more of the various medications, other fluids and/orother materials loaded onto a fluid delivery module can be deliveredsimultaneously with one another or sequentially.

Once the desired volumes or other quantities of medications,formulations and/or other substances have been delivered, the cliniciancan remove the needle from the patient and terminate the procedure 1046.However, in other embodiments, one or more additional treatment steps orprocedures may remain after the delivery of the desired medicationsand/or other substances. The needle, tip and/or any other component ofthe handpiece assembly (e.g., clip, delivery line, etc.), fluid deliverymodule (e.g., cassette, vials, etc.) or other portion of the injectionsystem can be properly discarded 1050 to reset 1054 the system inpreparation for a subsequent injection procedure.

Example No. 2

FIG. 54 schematically illustrates another example of ainjection/aspiration sequence 1100. With the exception of several stepsand other details, the depicted embodiment is similar to the sequence1000 discussed herein with reference to FIG. 53. For example, in theillustrated sequence 1100, once a targeted joint space or otheranatomical location has been located 1134, the clinician can detach thetip 1136 from the proximal portion of the handpiece assembly (e.g., theclip, core, etc.). Then, as discussed herein with reference to FIG. 44,a syringe or other vacuum source can be placed in fluid communicationwith the tip and the needle attached thereto in order to selectivelywithdraw fluids and/or other substances from the patient. For example,it may be beneficial or desirable to remove excess fluids from a damagedjoint before injecting one or more medications or formulations. Once adesired volume or other amount of fluid or other material have beenremoved from the patient, the clinician can reattach the tip 1138 andinitiate delivery of one or more medications, other fluids and/or othersubstances, as desired or required. For example, in one mode, a volumeof a second fluid or other material (e.g., steroids, anesthetics, otherpain-relieving medications, hyaluronic acid, saline, pharmaceuticalcompositions, cells, nanoparticles, cement, microbeads, etc.) isdelivered after a volume of a first medication (e.g., Lidocaine, otheranesthetic, pain-relieving medication, etc.) has been injected into thetargeted area. In other modes or sequences, the various medications,other fluids and/or other materials can be delivered to anintra-articular space simultaneously or according to a different order.

The above disclosure regarding the sequences for delivering medicationsand/or other materials to a target anatomical location and other relatedfeatures can be applied to any embodiment of an injection system, deviceor method disclosed herein or equivalents thereof.

To assist in the description of the disclosed embodiments, words such asupward, upper, bottom, downward, lower, rear, front, vertical,horizontal, upstream, downstream have been used above to describedifferent embodiments and/or the accompanying figures. It will beappreciated, however, that the different embodiments, whetherillustrated or not, can be located and oriented in a variety of desiredpositions.

Although several preferred embodiments and examples are disclosedherein, the present invention extends beyond the specifically disclosedembodiments to other alternative embodiments and/or uses of theinvention and modifications and equivalents thereof. It is alsocontemplated that various combinations or subcombinations of thespecific features and aspects of the embodiments may be made and stillfall within the scope of the invention. Accordingly, it should beunderstood that various features and aspects of the disclosedembodiments can be combine with or substituted for one another in orderto form varying modes of the disclosed invention. Thus, it is intendedthat the scope of the present invention herein disclosed should not belimited by the particular disclosed embodiments described above, butshould be determined only by a fair reading of the claims that follow.

1. A method of injecting a plurality of fluids into multiple patientsusing nonspecific fluid containers, comprising: providing an injectionsystem comprising a fluid delivery module and a handpiece; wherein thehandpiece comprises a clip, a disposable tip, a reusable core and atleast one controller; wherein the fluid delivery module comprises afirst loading area configured to secure a first container and a secondloading area configured to secure a second container; wherein said firstcontainer comprises a first fluid; wherein said second containercomprises a second fluid; wherein said loading areas are configured tosecurely receive containers of various types, shapes and sizes; whereinsaid fluid delivery module is configured to receive instructions fordelivering the first and second fluids for a first patient; wherein saidfluid delivery module is configured to receive instructions fordelivering the first and second fluids for a second patient; wherein theinstructions are modifiable between patients; wherein the fluid deliverymodule is configured to transfer at least a portion of the first fluidfrom the first container to a first reservoir; wherein the fluiddelivery module is configured to transfer a portion of the second fluidfrom the second container to a second reservoir; wherein the first andsecond reservoirs are positioned within a interior of the fluid deliverymodule; wherein a distal end of the disposable tip of the handpiece isconfigured to receive a first needle for use with a first patient and asecond needle for use with a second patient; wherein the disposable tipis configured to be disposed between patients; wherein the disposabletip comprises a valve to prevent reverse flow of the first and secondfluids from the needle into the clip of the handpiece; wherein saidhandpiece is configured to be in fluid communication with the first andsecond reservoirs of the fluid delivery module; wherein said handpieceis maneuverable to position the first or second needle within thepatient; and wherein said fluid delivery module and handpiece areconfigured to combine the first and second fluids prior to delivery tothe patient or are configured to administer the first and second fluidssequentially, depending on the instructions received by at least one ofthe fluid delivery module and the handpiece.
 2. The method of claim 1,wherein the at least one controller of the handpiece comprises at leastone button, said at least one button being configured to receiveinstructions for controlling at least one aspect of an injectionprocedure.
 3. The method of claim 1, wherein the fluid delivery moduleis configured to simultaneously or sequentially transfer a predeterminedvolume of the first fluid and the second fluid to a patient.
 4. Themethod of claim 1, wherein the fluid delivery module comprises a motorto facilitate the delivery of the first and second fluids to a patient.5. The method of claim 1, wherein the first fluid comprises ananesthetic.
 6. The method of claim 1, wherein the second fluid comprisesa steroid.
 7. The method of claim 1, wherein the first and second fluidsare delivered simultaneously to a joint in a patient.
 8. The method ofclaim 1, wherein the first and second fluids are delivered sequentiallyto a joint in a patient.
 9. The method of claim 1, wherein the injectionsystem further comprises a display configured to display informationregarding the delivery of the first and second fluids to a patient. 10.The method of claim 1, wherein the first container comprises anonspecific container.
 11. The method of claim 10, wherein thenonspecific container comprises a vial as supplied by a drugmanufacturer.
 12. The method of claim 1, further comprising monitoring aposition of the distal tip of the needle using an imaging deviceoperatively connected to said injection system to accurately locate atarget anatomical location of a patient.
 13. The method of claim 12,wherein the imaging device comprises an ultrasound device.